Electronic Biological Product Deviation Reporting (eBPDR)

Instructions for Using the eBPDR System

For use by biological product manufacturers to report biological product deviations (BPD) that may affect the safety, purity, or potency of a distributed product in accordance with 21 CFR, Part 600.14 or 606.171. Also for use by Human Cells, Tissues and Cellular and Tissue-Based Product (HCT/P) manufacturers to report HCT/P deviations in accordance with 21 CFR 1271.350(b).

General Instructions

My Establishments

To add an establishment

Select Establishment Screen

To enter a new report
To edit an unfinished report

Unfinished Reports

Availability of unfinished BPD reports
To open an unfinished BPD report for editing
To delete an unfinished BPD report
Availability of unfinished BPD Additional Information (AI) reports
To open an unfinished BPD Additional Information (AI) report for editing

Recently Submitted Reports

List of Active Users

Reporting Establishment Information

Deviation Establishment Information

Biological Product Deviation (BPD) Information

Description of Biological Product Deviation (BPD) Information

Description of Contributing Factors for BPD

Description of Follow-Up for BPD

Blood Products / Components Information (if blood product was selected)

Non-Blood Products Information (if non-blood product was selected)

Comments Section (blood products)

Comments Section (non-blood products)

BPD Report Preview Page

BPD Report Receipt Confirmation

Collection of BPD Additional Information (BPD AI) for Recall Classification Purposes

General Instructions

Accessing an Unfinished BPD AI Report

BPD AI - Updated Product Disposition Screen
BPD AI - Notification Method Screen
BPD AI - Distribution Pattern Information Screen
BPD AI - Industry Recall Contacts Screen
BPD AI - Preview Report Screen
BPD AI - Submitted Report Screen

Problems?

General Instructions

  • Complete all sections that apply to your report.
  • You should enter dates as month/day/year (e.g., March 1, 2000 = 03/01/2000). You may also select dates by using the popup calendar next to each date field.
  • If you do not know the exact dates, make your best guess.
  • All fields marked with an asterisk (*) are required fields and must be completed or you will not be permitted to move to the next page or submit the form. If you do not complete a required field the following message will appear: "You did not enter a value into the [field name] field. This is a required entry. Please enter it now." Click OK and enter a value in the specified field.

Note: We added enhanced navigation to allow users to skip to any page of a report that has been saved with all required information entered. The drop down navigation menu will display at the top of each screen upon accessing a report that you saved but have not submitted.

  • The contact person's email address is required to facilitate obtaining additional information regarding the BPD report.
  • The submitter's e-mail address is required to facilitate obtaining BPD Additional Information (AI) for recall classification purposes.
  • Complete a separate report for each BPD. If a BPD involves more than one product, only one report needs to be completed listing all distributed products affected.
  • DO NOT include donor, patient, or employee personal identification information or other confidential information.
  • DO NOT use this system to report Fatalities that occur as a result of collection or transfusion of blood or blood products. Fatalities must be reported in accordance with 21 CFR 606.170.
  • DO NOT use this system to report Adverse Experiences related to biological products other than blood or blood components or HCT/Ps. Adverse Experiences must be reported in accordance with 21 CFR 600.80 and, for HCT/Ps, 21 CFR 1271.350(a). Information regarding Adverse Experience Reporting is available at www.fda.gov/medwatch/. Information regarding Adverse Experience Reporting for vaccine products is available on our VAERS page.
  • Use the Tab key or mouse for on screen navigation.
  • For narrative entries, you may enter up to 3,999 characters (unless specified otherwise). If you enter more than the allowable number of characters, the additional characters will not be saved with your entry.
  • For any narrative entries, ASCII text information you may copy from another document source and paste into the narrative block.
  • Send amended or follow-up information to CBER via e-mail to bp_deviations@fda.hhs.gov. For amended or follow-up information to a HCT/P Deviation report, send an email to hctp_deviations@fda.hhs.gov. Please include the confirmation number of the original report.
  • Click the associated links located at the bottom of each page for:

    Select Another Establishment - returns to Select Establishment page (link not on Select Establishment page)

    CBER Home Page - returns to CBER'S home
    Contact eBPDR Technical Support - opens the support web form and allows you to send us a message.

    Help - provides on-line instructions to aid in completing the form

    Release Notes - provides most recent changes to the system

    Log Out - exits the system and returns to the Log In page

  • We recommend that you print these instructions for reference when completing the report. In addition to these instructions, you should also print the listing of the Biological Product Deviation Codes< (Deviation Codes), Product Codes for Blood(Blood Products) and Product Codes for Non-blood Products(Non-Blood Products, includes HCT/Ps) for quick reference. You can enter these codes manually into the report or select the code from the list of deviation codes.
  • After logging into the system you have 20 minutes to enter information and continue onto the next page (using the buttons at the bottom of the page). When you have been on a page for 17 minutes, a window will open and ask if you need more time. If you click "I need more time." you will be given an additional 20 minutes. If you do not respond when the window opens, and you have been on the page for more than 20 minutes, all information will be lost. You can also extend your time limit by 20 minutes at any time by pressing the Refresh button on the bottom of any page.
  • It is highly recommended that you do not use the back and forward buttons on your browser. Unexpected results may occur. Use the buttons on each page for form navigation.

My Establishments

To electronically report a Biological Product Deviation, a user's account must be associated with the establishment(s) for which they are reporting. You can create associations on the My Establishments page. Each establishment listed on this page will also appear in the "Select Your Establishment" drop down list on the Select Establishment screen.

  • You will need your establishment identification number and identification number type (e.g; FEI) to add the establishment.
  • The reporting establishment is the establishment who had control over the product at the time the BPD occurred.

For example:

  • A BPD that occurs at a Source Plasma collection center should be reported by that center and not by the corporate office
  • A BPD that occurs at an auxiliary facility (e.g., donor center, distribution center) operating under a blood bank or blood center should be reported by the blood bank or blood center
  • A BPD that occurs at one of several locations of a licensed establishment, should be reported by the location who had control over the product, not by the headquarters location
  • A BPD that occurs at a contract manufacturing site (e.g., test laboratory, filling facility), should be reported by the license holder of the product.
  • A HCT/P deviation that occurs at an establishment that makes the HCT/P available for distribution or in a facility that is under contract agreement or other arrangement should be reported by the establishment who determined that the HCT/P met all release criteria and made the HCT/P available for distribution.

Registration Number - either a Central File Number (CFN), which is a 7 digit number or an FDA Establishment Identifier (FEI), which may be up to 10 digits assigned to your facility if you have completed an FDA Form 2830 for blood establishments, FDA Form 2656 for drug manufacturers, FDA Form 2891 for device manufacturers, or FDA Form 3356 for HCT/Ps. If you have a license number you will also have a registration number. FDA's Office of Regulatory Affairs (ORA) districts will no longer assign CFN's to new facilities as of October 1, 2001. Instead, only FEI numbers will be assigned.

CLIA Number - a 10 character number that is assigned by the Centers for Medicare and Medicaid Services (CMS-formerly HCFA) to facilities who are eligible for Medicare reimbursement. Only provide this number if you do not have a registration number.

You may contact your local FDA district office to obtain your registration number from the appropriate Registration Monitor (Blood, Device, or Drug). A listing of the Registration Monitors is available at: http://www.fda.gov/ora/inspect_ref/iom/iomoradir_monitors.html. Foreign establishments may contact the Office of Regional Operations, Division of Emergency and Investigational Operations (ORA/ORO/DEIO) at 301-827-5653. For a valid CLIA number contact your CLIA State Survey Agency. The State Agency telephone numbers and contact people are listed on CMS's web site at http://www.cms.hhs.gov/clia/.

To add an establishment

  • Enter the Establishment Identification Number and select the Establishment Identification Number Type then press the Add to My Establishments button.
  • A confirmation screen will appear if you have entered a valid Identification Number and Number Type. By pressing the Yes button, you are agreeing that you are a valid representative of this establishment and may legally submit Biological Product Deviation reports for this establishment. Press the No button to cancel your association request and return to the previous page.
  • Repeat this process for each establishment with which you want to request an association.

To remove an establishment

  • If you wish to remove your association with an establishment, select the establishment and press the Remove From List button.
  • A confirmation screen will appear asking if you are sure you want to remove your association to this establishment. Press OK to remove the establishment or press Cancel to cancel your request.

Buttons - My Establishments Screen

  • Add To My Establishments - associates your account to the establishment you entered.
  • Remove From List - removes your association with an establishment.
  • Select Establishment Screen - proceeds to the Select Establishment page.

Select Establishment Screen

To enter a new report

  • Select your establishment using the drop down list
  • Press Create New Report

To edit an unfinished report

Unfinished BPD Reports

  • Select your establishment
  • Enter your report Pre-Confirmation Number (P#). P# is assigned to a previously saved report not yet submitted to the FDA.
  • Press Edit Report.
  • Alternately, you may access your saved but not submitted BPD reports by pressing Unfinished Reports.

Unfinished BPD Additional Information (AI) reports for recall classification purposes.

  • You may access your available BPD Additional Information (AI) reports by pressing Unfinished Reports.

Buttons - Select Establishment Screen

  • My Establishments - proceeds to the My Establishments screen.
  • Create New Report - proceeds to the Reporting Establishment Information page. You must select your establishment before pressing this button.
  • Edit Report - retrieves an existing report and proceeds to the Reporting Establishment Information page. You must first select your establishment and enter the report P# before pressing this button.
  • Unfinished Reports - displays a listing of previously saved reports not yet submitted to the FDA.
  • Submitted Reports - diplays a listing of the reports you submitted within the past 90 days.
  • List of Active Users - displays other users associated to your establishments.
  • eBPDR User Guide - instructions for using the eBPDR system
  • CBER On-Line Main Menu - exits the eBPDR system and displays the CBER On-Line Main Menu.

Unfinished Reports

The Unfinished Reports page may display two different kinds of reports; BPD Reports and BPD Additional Information(AI) Reports. BPD reports that you have modified within the last 30 days but not submitted to the FDA will display on the Unfinished Reports page under the section Unfinished BPD Reports.

BPD Additional Information (AI) Reports, used for the collection of BPD AI for recall classification purposes, will display on the Unfinished Reports page under the section Unfinished BPD Additional Information (AI) Reports until they are submitted to FDA.

Within each section, reports will be grouped by establishment if you have unfinished reports for multiple establishments.

Availability of unfinished BPD reports

  • Please note that a BPD report is available for editing up to 30 days after you last modified it, this date is reflected in the column "Available Until". Reports that are not modified within the past 30 days will be removed from the system.
  • Once you submit the report to the FDA, it will no longer display on the Unfinished Reports page.

To open an unfinished BPD report for editing

  • Press the Edit P-### button next to a report to open it for editing.

To delete an unfinished BPD report

  • Press the Delete P-### button next to a report to delete it.

Availability of unfinished BPD Additional Information (AI) reports

  • Please note that an unfinished BPD Additional Information (AI) report is available until submitted to FDA.
  • Once you submit the report to the FDA, it will no longer display on the Unfinished Reports page.

To open an unfinished BPD Additional Information (AI) report for editing

  • Press the Edit AI-### button next to a report to open it for editing.
  • Directions for completing a BPD Additional Information (AI) report can be found in the following section of this document; Collection of BPD Additional Information BPD (AI) for recall classification purposes

If you need assistance, you may e-mail CBER_RecallAlerts@fda.hhs.gov.

Buttons - Unfinished Reports Screen

  • Edit P-### - opens the BPD report for editing and proceeds to the Reporting Establishment Information page.
  • Delete P-### - deletes the BPD report.
  • Edit AI-### - opens the BPD Additional Information (AI) report for editing and proceeds to the Updated Product Disposition page.
  • Select Establishment Screen - proceeds to the Select Establishment page.

Submitted Reports

BPD Reports that you submitted to the FDA within the last 90 days will display on the Recently Submitted Reports page. Reports will be grouped by establishment if you have submitted reports for multiple establishments. Please note that submitted BPD Additional Information (AI) reports are currently not accessible for viewing after being submitted to FDA.

Availability of submitted reports

  • A report is available up to 90 days after you submitted it. This date is reflected in the column "Submit Date". Reports are displayed in descending order by submit date.
  • Please note that the display will only include reports for establishments with which your account is currently associated.

To open a submitted report

  • Press the View ### button next to a report to open it.

Buttons - Recently Submitted Reports Screen

  • View ### - opens the report and allows you to print or save the report.
  • Select Establishment Screen - proceeds to the Select Establishment page.

List of Active Users

This page will display other users that are associated to the same establishment you have listed on your "My Establishments" page.

  • Please review this list periodically and contact eBPDR Technical Support if you find unfamiliar names listed or need names removed.
  • If one of your establishments is not listed, it means that you are the only user account associated to that establishment.
  • If one of your establishments is listed it will display the following information:
    • Establishment Identification Number and Type
    • Establishment Name
    • Full Name (Last Name, First Name, MI) of other users associated with that establishment.

Buttons - Active Users Screen

  • Select Establishment Screen - proceeds to the Select Establishment page.

Reporting Establishment Information

The establishment information corresponding to the Establishment Identification Number selected is automatically populated. Verify that this information is correct. If an incorrect establishment identification number was entered, return to Select Establishment page. If the establishment identification number is correct, but the information displayed is incorrect, Contact eBPDR Technical Support.

Enter the following information in the event we need more information or need to contact you:

  • Telephone Number - The telephone number of the person who is the point of contact
  • Point of Contact - Name of the person who is the point of contact for the report
  • Contact Email Address - The E-mail address of the person who is the point of contact - this must be in the form of a valid email address
  • Submitter Email Address - The E-mail address of the person entering the report. The field pre-populates with your CBER Online user account email address after creating a new BPD report using the ‘Create New Report' button. To change the CBER Online account email address, access the CBER Online Main Menu and then press the Edit Current Account button.
  • Tracking Number - Your establishment's internal tracking number to identify individual reports. This number should consist of no more than 25 numbers and/or characters. The tracking number should not be your establishment identification number. It should be a unique identifier for each report. Your system of assigning tracking numbers should not allow for duplicate numbers.
  • Please check here if the Deviation did not occur at this Reporting Establishment - Check this box if the BPD occurred at a contract facility under your control or at another facility under your control such as an auxiliary facility (e.g., donor center, distribution center). After you press continue, the system will prompt you to enter information about the facility where the deviation occurred.

Buttons - Reporting Establishment Information Screen

  • Continue - saves changes and proceeds to the Biological Product Deviation (BPD) Information page
  • Refresh - extends the time for completing the page by 20 minutes
  • Reset - resets entered values to the values saved in the database

Deviation Establishment Information

If the BPD occurred at an establishment other than the reporting establishment, please enter as much information as possible about the establishment where the deviation occurred.

  • Establishment Identification number
  • Establishment Identification number Type (FEI, CLIA, or CFN)
  • Establishment Name and address

If you enter information on the Deviation Establishment page and uncheck the box indicating the deviation did not occur at the reporting establishment, the information on the Deviation Establishment page will be removed.

Buttons - Deviation Establishment Information Screen

  • Previous - saves changes and returns to the previous page
  • Continue - saves changes and proceeds to the next page
  • Refresh - extends the time for completing the page by 20 minutes
  • Reset - resets entered values to the values saved in the database

Biological Product Deviation (BPD) Information

Enter as much information as possible about the deviation

  • Date BPD Occurred - The date the deviation or unexpected event occurred. Please enter using the format mm/dd/yyyy.
  • Date BPD Discovered - The date the deviation or unexpected event was discovered. The date discovered is the date you acquire information reasonably suggesting that a reportable event has occurred. If the event occurred at your contractor, the date of discovery is when the contractor learns about the deviation or unexpected event. Please enter using the format mm/dd/yyyy.
  • Date BPD Reported - The date the report is completed. Please enter using the format mm/dd/yyyy. This date is auto-populated with the current date upon creating the report. If you save the report for retrieval and submit at a later date, please update this date accordingly prior to submittal.
  • Type of Product - Check either Blood Product or Non-Blood Product to identify the type of product potentially affected by the BPD.
    • Blood Product - includes products manufactured by blood and plasma establishments, such as whole blood, red blood cells, fresh frozen plasma, platelets, and plasma for further manufacture and Source Plasma.
    • Non-Blood Product - includes products manufactured by a facility other than blood establishments, such as vaccines, therapeutics, allergenics, in-vitro diagnostics, plasma derivatives, and HCT/Ps.
  • Total Number of Unit(s) - Enter the total number of units. For example, if one unit of whole blood was manufactured into Red Blood Cells, Fresh Frozen Plasma and Platelets, the total number of units is 1 and the number of components is 3.
  • Total Number of Component(s) / Lot(s) - Enter the total number of components (for blood products) or lots (for non-blood products) potentially affected by the BPD.
  • BPD Code - Enter the code from the BPD Code listing that best describes the BPD.
    • Select BPD Code: Displays a selectable list of BPD codes and populates the BPD code field with the user's selection. The description of the BPD Code automatically populates.
    • Show Description: Displays the description of the BPD Code if you manually enter any or all 3 parts of the BPD Code, If you change the BPD code, press the Show Description button to update the description of the BPD code.
    • Use the Blood Deviation Codes for the BPD's involving blood products.
    • Use the Non-Blood Deviation Codes for the BPD's involving non-blood products.
    • Use the HCT/P deviation codes for the deviations involving HCT/Ps.

The BPD Code is made up of three levels.

The first level | XX | - | | - | | identifies the system affected in which there was a breakdown or failure, which resulted in the distribution of an unsuitable product. Use the appropriate guidance document for determining the system affected.

For blood products the systems include: For non-blood products the systems include: For HCT/Ps the systems include:
PD - Post Donation Information IM - Incoming Material Specifications DE - Donor Eligibility
DS - Donor Screening PC - Process Controls DS - Donor Screening
DD - Donor Deferral TE - Testing DT - Donor Testing
BC - Blood Collection LA - Labeling EC - Environmental Control
CP - Component Preparation PS - Product Specifications SR - Supplies and Reagents
VT - Viral Testing QC - Quality Control and Distribution RE - Recovery
RT - Routine Testing MI - Miscellaneous PC - Processing and Process Controls
LA - Labeling   LC - Labeling Controls
QC - Quality Control and Distribution   ST - Storage
MI - Miscellaneous   SD - Receipt, Pre-Distribution, Shipment and Distribution

The second level | | - | YY | - | | is a subset of the system affected.

The third level | | - | | - | ZZ | contains more detailed information regarding the BPD. Select the code that most closely describes the deviation or unexpected event (see BPD Code Listing). If you cannot determine the appropriate code, enter question marks. For example: ??-??-?? or LA-??-??

Buttons - BPD Information Screen

  • Previous - saves changes and returns to the previous page
  • Continue - saves changes and proceeds to the next page
  • Refresh - extends the time for completing the page by 20 minutes
  • Reset - resets entered values to the values saved in the database

Description of Biological Product Deviation (BPD) Information

Description of BPD - Describe the event in detail, including a description of what happened and a summary of all relevant information (labeling, test results, reason for donor deferral, etc.). Do not include any confidential information, such as patient, donor or employee names.

  • You may enter a maximum of 3999 characters. As you type, a counter below the text field will display the number of allowable characters remaining for entry.
  • Please note if you enter more characters than allowed, the excess characters are removed from the screen automatically and are not saved to the database.

Buttons - Description of BPD Screen

  • Previous - saves changes and returns to the previous page
  • Continue - saves changes and proceeds to the next page
  • Refresh - extends the time for completing the page by 20 minutes
  • Reset - resets entered values to the values saved in the database

Description of Contributing Factors for BPD

Description of Contributing Factors or Root Cause - Describe all contributing factors or root causes of the deviation or unexpected event. Please indicate, if after investigation, a root cause cannot be determined.

  • You may enter a maximum of 3999 characters. As you type, a counter below the text field will display the number of allowable characters remaining for entry.
  • Please note if you enter more characters than allowed, the excess characters are removed from the screen automatically and are not saved to the database.

Buttons - Description of Contributing Factors Screen

  • Previous - saves changes and returns to the previous page
  • Continue - saves changes and proceeds to the next page
  • Refresh - extends the time for completing the page by 20 minutes
  • Reset - resets entered values to the values saved in the database

Description of Follow-Up for BPD

Follow-up - Describe the intended short term and long term follow-up action plans, if applicable. You do not have to implement the corrective action identified at the time of filing this report. If you perform consignee notification or product retrieval, please indicate the date and method (letter, fax, telephone, etc.) of notification.

  • You may enter a maximum of 3999 characters. As you type, a counter below the text field will display the number of allowable characters remaining for entry.
  • Please note if you enter more characters than allowed, the excess characters are removed from the screen automatically and are not saved to the database.

Buttons - Description of Follow-Up Screen

  • Previous - saves changes and returns to the previous page
  • Continue - saves changes and proceeds to the next page
  • Refresh - extends the time for completing the page by 20 minutes
  • Reset - resets entered values to the values saved in the database

Blood Products / Components Information (if you selected blood product)

Blood Products / Components Information page will display if you select Blood Product on the BPD Information page. You will enter each component on a separate page.

  • First enter each component for which you have all the *Required information
  • After entering a component, press the Continue button to open the next component page. When you've finished entering all components the continue button will take you to the BPD Report Preview page.
  • If you do not have all of the required information for a component, press the Finish button and enter as much information as possible in the comments section.

For each component provide the following:

  • Unit # - donor number or bleed number
  • Collection date - the date the unit was collected. If the collection date is not known, leave this field blank.
  • Expiration date - the date the component expires. If the expiration date is not applicable (e.g., for Recovered Plasma), leave this field blank.
  • Blood Product Code - specific blood product code. Use the link (Blood Product Codes) to display a list of blood products. Use the code YY01 for products for further manufacture, such as recovered plasma. Use the code DB00 for products not listed on the Blood Products Code List, such as IVIG or albumin (if the blood establishment distributed it) and specify the product in the Additional Information Section.
  • Disposition - provide the disposition of the product using the drop down lists - DO NOT list any products that were not distributed.
    • In the first field, specify if the unit was:
      • Distributed in-house - distributed from the blood bank within a hospital to another department, e.g., emergency room, surgery, nursing floor, etc.
      • Distributed to another facility - distributed from a blood center to a hospital, from one hospital to another, or from a blood or plasma establishment to a manufacturer of biological products other than blood or blood components.
    • In the second field, specify the disposition using the following descriptions:
      • No information - product distributed, information regarding final disposition not available at time of reporting
      • Corrected by consignee - product distributed and deviation corrected by consignee
      • Destroyed by consignee - product distributed and destroyed by consignee
      • Expired - product distributed and is now expired, no other information available
      • Returned and corrected - product distributed, returned to manufacturer and deviation corrected
      • Returned and destroyed - product distributed, returned to manufacturer and destroyed
      • Sent for further manufacturing - product distributed for further manufacture
      • Sent for further manufacturing of non-injectable products only - product distributed for further manufacture into non-injectable products only
      • Transfused - product distributed and transfused to a patient
      • Other - (Explain in Additional Info.) - if other is selected, please explain in Additional Information

Notification - provide either yes or no to identify whether you notified a consignee. If the consignee notified you of the deviation or unexpected event, select RN for reverse notification.

The following are examples of how to report the disposition and notification information:

The blood bank distributed a unit of RBC's to the nursing floor. Prior to transfusion the nurse discovers a discrepancy in labeling. The nurse returns the unit to the blood bank and the blood bank corrects the label. The unit is reissued and transfused.

  • Disposition: Distributed in-house/Returned and corrected
  • Notification: RN (reverse notification)

The blood center distributed a unit of RBC's to a hospital. The blood center discovers a deviation in testing the unit and notifies the hospital to return the unit. The unit was transfused prior to notification from the blood center.

  • Disposition: Distributed to another facility/Transfused
    o Notification: Y (yes)

Additional Information - use this section to further explain product information, such as product code, product disposition, or notification.

You may also use the additional information section to enter components manufactured from one whole blood unit. For example enter the component information for RBC (DB29). In the additional information section enter the component information that's different for the remaining components (expiration date, product code, disposition, notification)

09/16/2001 DB53 Distributed to another facility, Returned and corrected Y
09/16/2001 DB05 Distributed to another facility, Transfused N
09/21/2000 DB45 Distributed in-house, Transfused Y

Buttons - Blood Products / Components Screen

  • Previous - saves changes and returns to the previous page
  • Continue - saves changes and proceeds to the next page
  • Refresh - extends the time for completing the page by 20 minutes
  • Finish - saves changes and
    • proceeds to Comments page if all components are not completed or
    • proceeds to BPD Report Preview page if all components are completed
  • Delete - deletes the displayed product information page and returns to previous page
  • Reset - resets entered values to the values saved in the database

Non-Blood Products Information (if you selected non-blood product)

Non-Blood Products Information will display if you selected Non-Blood Product on the BPD Information page. You will enter each lot on a separate page.

  • First enter each lot for which you have all the *Required information
  • After entering a lot, press the Continue button to open the next lot page. When you've finished entering all lots the continue button will take you to the BPD Report Preview page.
  • If you do not have all of the required information for a lot, press the Finish button and enter as much information as possible in the comments section.

For each lot provide the following:

  • Lot # - lot number of the product
  • Expiration Date - the date the product expires
  • Product Type - major category of products, which may be selected using the drop down list:
    • Allergenics
    • Derivatives
    • In-Vitro Diagnostics
    • Therapeutics
    • Vaccines
    • "351" HCT/Ps *
    • "361" HCT/Ps **

    * "351" HCT/Ps - Human cells, tissues and cellular and tissue-based products (HCT/Ps) that are regulated as biological products under section 351 of the Public Health Service Act and the Food, Drug, and Cosmetic Act because they do not meet the criteria in 21 CFR 1271.10(a).

    ** "361" HCT/Ps - Human cells, tissues and cellular and tissue-based products (HCT/Ps) that are regulated solely under section 361 of the Public Health Service Act because they meet all of the criteria in 21 CFR 1271.10(a).

  • Non-Blood Product Code - specific non-blood product code. Click the link Non-Blood Product Codes to display a list of non-blood products.
  • Disposition - provide the disposition of the product using the drop down list - DO NOT list any products that were not distributed. Valid dispositions are:
    • Destroyed by consignee - product distributed and destroyed by consignee
    • Distributed - product distributed, information regarding final disposition not available at time of reporting
    • Expired - product distributed and is now expired, no other information available at time of reporting
    • Returned and destroyed - product distributed, returned to manufacturer and destroyed
    • Returned and reworked - product distributed, returned to manufacturer and reworked according to an appropriate procedure
    • Sent to distributor - product distributed to a facility outside of your control for further distribution
    • Other (Explain in Additional Info.) - if other is selected, please explain in Additional Information
  • Notification - provide either yes or no to identify whether you notified a consignee.
  • Additional Information - use this section to further explain product information, such as product code, product disposition, or notification.

Buttons - Non-Blood Products Information Screen

  • Previous - saves changes and returns to the previous page
  • Continue - saves changes and proceeds to the next page
  • Refresh - extends the time for completing the page by 20 minutes
  • Finish - saves changes and
    • proceeds to Comments page if all lots are not completed or
    • proceeds to BPD Report Preview page if all lots have been entered.
  • Delete - deletes the displayed product information page and returns to previous page
  • Reset - resets entered values to the values saved in the database

Comments Section (blood products)

If you do not have all of the required information for a component, enter as much information as possible in the comments section. If multiple units have the same information (i.e., collection date, expiration date, product, disposition and notification) enter the information for the first unit number and list the additional unit numbers in this section. If more than 18 units were potentially affected, enter the product information for the first 18 units and enter the remaining unit numbers in this section. You may copy information to this section from another source in ASCII text.

  • You may enter a maximum of 3,999 characters. As you type, a counter below the text field will display the number of allowable characters remaining for entry.
  • Please note if you enter more characters than allowed, the excess characters are removed from the screen automatically and are not saved to the database.

After entering information in the Comments Section, press the Continue button. Electronic Biological Product Deviation Report Preview page will display.

The following are examples of ways to enter information when multiple units are involved:

  1. Information for one component (unit number 1234) entered on the Blood Products/Components Information Page and there are additional units with the same information:
    • Comments Section: Additional units - 1235, 1236, 1345, 1844, 2900 and 4344
  2. . Information for 18 components entered on the Blood Products/Components Information Page, additional component information entered in the Comments Section (2 examples)
    • A) Additional products - Transfused, No Notification - Product Code DB29: 01X1111, 01X0000, 01X2222, 01X3333, 01X4444. Product Code DB56: 01X5555, 01X6666, 01X77777, 01X8888, 01X9999.
    • B) Additional products - Notification: Yes - 25 DB29 Distributed; 6 DB56 Distributed; 1 DB00 (pediatric aliquot) Distributed; 1 DB01 Distributed; 1 DB05 Distributed; 1 DB45 Transfused; 7 DB53 Distributed; 25 YY01 Sent for further manufacturing.

Buttons - Comments Section Screen (Blood Products)

  • Previous - saves changes and returns to the previous page
  • Continue - saves changes and proceeds to the next page
  • Refresh - extends the time for completing the page by 20 minutes
  • Reset - resets entered values to the values saved in the database

Comments Section (non-blood products)

If you do not have all of the required information for a lot, enter as much information as possible in the comments section. If multiple lots have the same information (i.e., expiration date, product code, disposition and notification) enter the information for the first lot number and list the additional lot numbers in this section. If more than 18 lots were potentially affected, enter the product information for the first 18 lots and enter the remaining lot numbers in this section. You may copy information to this section from another source in ASCII text.

  • You may enter a maximum of 3,999 characters. As you type, a counter below the text field will display the number of allowable characters remaining for entry.
  • Please note if you more characters than allowed, the excess characters are removed from the screen automatically and are not saved to the database.

After entering information in the Comments Section, press the Continue button. Electronic Biological Product Deviation Report Preview page will display.

The following are examples of ways to enter information when multiple lots are involved:

  1. Information for one lot entered, additional lots with same information entered in the Comments Section:
    Additional lots- 1235, 1236, 1345A, 1345B
  2. Product information entered for 18 lots, additional lot information entered in Comments Section: Additional products - Distributed, No Notification - Product Code GR65: X0111, X0022, X2244, Product Code GS22: S5555, S6666, S7777, Product Code: GS34: T8888, T9999.

Buttons - Comments Section Screen (Non-Blood Products)

  • Previous - saves changes and returns to the previous page
  • Continue - saves changes and proceeds to the next page
  • Refresh - extends the time for completing the page by 20 minutes
  • Reset - resets entered values to the values saved in the database

BPD Report Preview Page

The Electronic Biological Product Deviation Report Preview page is displayed with all of the information entered. Review the information to verify accuracy. Please note that you have 30 days to modify or submit the report to FDA. Reports that you have not edited or submitted after 30 days will be deleted and you will have to re-enter the information in a new BPD report.

  • Submit To FDA - If all information is correct press the Submit to FDA button to send the report to FDA. If all required information is present, the Electronic Biological Product Deviation Receipt Confirmation will be displayed.
  • Delete This Report - To remove the report from the system, press the Delete button. You will be asked if you want to delete this record. Press the OK button to delete the report. Press cancel to return to the report.
  • Enter Another Deviation - To enter another report from the same reporting establishment, click the link Enter Another Deviation.
  • Select Another Establishment - To enter another report from a different reporting establishment, or retrieve an existing report click the link Select Another Establishment.

Buttons at bottom of page

  • Previous Page - If any information is inaccurate, press the Previous Page button to edit your report. You may also use drop down navigation located at the top of the screen to select a page for further editing.
  • Delete - To remove the report from the system, press the Delete button. You will be asked if you want to delete this record. Press the OK button to delete the report. Press cancel to return to the report.
  • Submit To FDA - If all information is correct press the Submit to FDA button to send the report to FDA. If all required information is present, the Electronic Biological Product Deviation Receipt Confirmation will be displayed.
  • Refresh - Press the Refresh button to extend your session 20 additional minutes.

BPD Report Receipt Confirmation

When the report is Submitted to FDA, the Electronic Biological Product Deviation Receipt Confirmation page is displayed with all of the information entered. Please refer to the Report Confirmation number in the event additional correspondence is needed. Once you submit the report to FDA, a window will open as a reminder to print the report. To print a hard copy of the report, press the Print button on your browser. This report is for your records.

  • Enter Another Deviation - To enter another report from the same reporting establishment, click the link Enter Another Deviation.
  • Select Another Establishment - To enter another report from a different reporting establishment, or retrieve an existing report click the link Select Another Establishment.

Collection of BPD Additional Information (AI) for Recall Classification Purposes

BPD AI - For use by biological product manufacturers to provide information for recall classification purposes in accordance with 21 CFR, Part 7 Enforcement Policy; Subpart C - Recalls (Including Product Corrections) - Guidance on Policy, Procedure, and Industry Responsibilities). The collection of additional information associated with a BPD for the purpose of recall classification will be requested through an e-mail notification to the submitter of the BPD.

If you need assistance, you may e-mail CBER_RecallAlerts@fda.hhs.gov.

General Instructions for Completing the BPD Additional Information (AI) Reports:

  • It is recommended that you print these instructions for reference when completing the BPD AI report.
  • Complete a separate BPD AI report for each BPD AI request that you received an e-mail notification regarding.
  • Complete all sections that apply to your report.
  • Only the unit/lot numbers and product codes for which CBER requests more information will appear pre-populated in the BPD AI report.
  • Date fields may be entered in mm/dd/yyyy format or selected by using the popup calendar next to each date field. If exact dates are not known, make your best guess.
  • Required Fields (*) and Conditionally Required Fields (**) are designated on screen and specific instructions are provided either on screen or in this document.
  • All fields marked with an asterisk (*) are required fields and must be completed or you will not be permitted to proceed to the next screen or submit the form. If a required field is not entered, a message will display indicating which field must be entered.
  • All fields marked with (**) are conditionally required fields based on your responses. When required, these fields must be completed or you will not be permitted to proceed to the next screen or submit the form
  • Navigate within a screen using the mouse or the Tab key.
  • Navigate from screen to screen using buttons at the bottom of each page. It is highly recommended that you do not use the back and forward buttons on your browser as unexpected results may occur.
  • After logging into the system, you have an active session for 20 minutes. Each time you navigate from screen to screen or save data using the on screen Save button, your session is refreshed and you have an additional 20 minutes to proceed. After 17 minutes of inactivity, a window will open and ask if you need more time. If you click "I need more time." you will be given an additional 20 minutes. If you do not respond within 3 minutes, your session will end and any unsaved changes will be lost.
  • Send amended or follow-up information to CBER via e-mail to CBER_RecallAlerts@fda.hhs.gov. Please include the confirmation number of the original BPD report.
  • Unless specifically requested, please do not send recall associated paperwork to your local district office for recall classification purposes.

Accessing an Unfinished BPD AI Report

When additional information is requested, a BPD AI report entry will appear on the Unfinished Reports screen for the user account which submitted the original BPD report.

Note: Only the user account which submitted the original BPD report currently has access to the corresponding BPD AI report.

To provide BPD Additional Information (AI) access to multiple authorized representatives, you may create a single user account to submit future BPD reports.

  • From the eBPDR Select Establishment screen, navigate to the Unfinished Reports screen by pressing the Unfinished Reports button.
  • BPD AI reports will display in the section ‘Unfinished BPD Additional Information (AI) Reports'.
  • To open an unfinished BPD AI report for editing, press the Edit AI-### button for the desired report. The system will navigate to the BPD AI - Updated Product Disposition screen.
  • An unfinished BPD AI report will display on the Unfinished Reports screen until the report is submitted to FDA.

If you need assistance, you may e-mail CBER_RecallAlerts@fda.hhs.gov.

BPD AI - Updated Product Disposition Screen

Provide the following additional information for products distributed to another facility. Verify consignee(s) were notified and if notified, provide dates of distribution and final disposition(s).

  • (*) Verify Consignee Notified - Use the drop down pick list to verify ‘Yes' or ‘No' as to whether consignee(s) were notified. Select ‘RN' for reverse notification if a consignee notified you of the deviation,
    • A value of ‘Yes', ‘No', or ‘RN' must be selected for each product.
    • If ‘No' or ‘RN' is selected for all products, press Continue.
    • If ‘Yes' is selected for one or more products, please continue completing the screen.
  • (**) Date Distributed (mm/dd/yyyy) - Provide the distribution date for each product. Entry is required when Verify Consignee Notified equals ‘Yes'. The Distribution Date is the date the product was distributed to Another Facility (AF) - distributed from a blood center to a hospital, from one hospital to another, or from a blood or plasma establishment to a manufacturer of biological products other than blood and blood components.
  • (**) Final Disposition - Select the final disposition for each product. Entry is required when Verify Consignee Notified equals ‘Yes'. Final Disposition values are:
    • ‘Transfused' - product distributed and transfused to a patient
    • ‘Destroyed by Consignee' - product distributed and destroyed by consignee
    • ‘Returned and Destroyed' - product distributed, returned to manufacturer and destroyed
    • ‘Corrected by Consignee' - product distributed and deviation corrected by consignee
    • ‘Returned and Corrected' - product distributed, returned to manufacturer and deviation corrected
    • ‘Sent for Further Manufacturing' - product distributed for further manufacture
    • ‘Sent for Further Manufacturing of non-injectable products only' - product distributed for further manufacture into non-injectable products only
    • ‘Culled from Manufacturing to be destroyed by Consignee' - product distributed and is to be destroyed by consignee
    • ‘Destroyed during Manufacturing' - product distributed and destroyed by consignee during manufacture
    • ‘In-house distribution' (IH) - products distributed between facilities with the same license numbers such as ARC to ARC are not considered distributed for recall classification purposes unless the product is further distributed outside the ARC. Note: In-house distribution (IH) is not considered distributed for the purposes of recall classification.
    • ‘No Information' - product distributed, information regarding final disposition not available at time of reporting
    • ‘Other' - if other is selected, provide further details in the comments field.
  • (**) Product Information Comments - Entry is required if "Other" is selected as a final disposition.
  • If you chose a non-specific product code on your BPDR (e.g., DB00), provide the name of the product(s) in the Comments field. You may skip this step if you included this information on your BPDR. 2000 characters maximum.

Buttons - BPD AI - Updated Product Disposition Screen

  • Continue - saves changes and navigates to the BPD AI - Notification Method Screen, unless all “Verify Consignees Notified” value equals ‘No' or ‘RN' then Continue button navigates to the Preview Reports Screen.
  • Save - commits any changes to the database

Required Fields - designated by the symbol (*)
Conditionally Required Fields - designated by the symbol (**)

If you need assistance, you may e-mail CBER_RecallAlerts@fda.hhs.gov.

BPD AI - Notification Method Screen

Provide method(s) and date(s) of consignee notification. If your method of notification is not one of the available choices, select "Other" and describe the notification method in the Comments field.

  • (*) Initial Notification #1 - Entry of Initial Notification (#1) Method and Date are required.
  • Initial Notification #2 - Provide a second initial notification method and date if needed.
  • Further Notifications - Provide further notification method(s) and date(s) if needed.
  • (**) Notification Comments - Entry is required if "Other" is selected as a notification method.
  • (*) Recall Completion Date (mm/dd/yyyy) - Provide the recall completion date. Recall Completion Date is the latest date of consignee notification.

Buttons - BPD AI - Notification Method Screen

  • Previous - saves any changes and navigates to the BPD AI - Updated Product Disposition screen
  • Continue - saves changes and navigates to the BPD AI - Distribution Pattern Information screen
  • Save - commits any changes to the database

Required Fields - designated by the symbol (*)
Conditionally Required Fields - designated by the symbol (**)

BPD AI - Distribution Pattern Information Screen

Provide the states (for products distributed within the United States) and/or the countries (for products distributed outside the United States) where the products were distributed.

  • (*) Distribution Pattern - Entry of Distribution Pattern is required. Populate the field using the Domestic and Foreign multi-select list of values. To use the multi-select lists:
    • Select a state from the Domestic list of values (or hold down CTRL on your keyboard and select multiple states) and press Add State to Distribution Pattern. The selected values will be added to the distribution pattern field.
    • Select a country from the Foreign list of values (or hold down CTRL on your keyboard and select multiple countries) and press Add Country to Distribution Pattern. The selected values will be added to the distribution pattern field.
    • Select Clear Distribution Pattern to clear a Distribution Pattern entry.

Provide counts related to the distribution pattern.

  • (*) Domestic Consignees (total) - Enter the number of Domestic Consignees (located within U.S). Enter zero if appropriate. Entry is required.
  • (*) Foreign Consignees (total) - Enter the number of Foreign Consignees (located outside U.S). Enter zero if appropriate. Entry is required.

Note: The sum of Domestic and Foreign Consignee totals must equal 1 or more.

  • # of Distributors - Enter the number of consignees that are Distributors
  • # of Medical Facilities - Enter the number of consignees that are Medical Facilities.
  • # of Veterans Admin - Enter the number of Veterans Administration consignees
  • # of Dept. Of Defense - Enter the number of Department of Defense consignees.
  • # of Manufacturers - Enter the number of consignees that are Manufacturers
  • # of Other - Enter the number of other consignees that are not specified above. If “other” is selected, describe the type of facility in the comments field.

Provide comments

  • Distribution Pattern Comments - Describe the type of facility in the Comments field if "# of Other" is entered above. Additionally, if you distributed products to Canada, a U.S. federal government and/or Department of Defense (DoD) facility, please provide the consignee name and address in the comments field. 2000 characters maximum.

Buttons - BPD AI - Distribution Pattern Information Screen

  • Previous - saves any unsaved changes and navigates to the BPD AI - Notification Method screen
  • Continue - saves any unsaved changes and navigates to the BPD AI - Industry Recall Contacts screen
  • Save - commits any changes to the database

Required Fields - designated by the symbol (*)
Conditionally Required Fields - designated by the symbol (**)

BPD AI - Industry Recall Contacts Screen

Provide contact information for the Recalling Firm's Most Responsible Individual and Recall Contact.

Most Responsible Individual

  • (*) Official's Name
  • Title
  • (*) Firm Name
  • (*) Address Line 1
  • Address Line 2
  • (*) City
  • (**) State/Province (required only for US and Canada)
  • (*) Country
  • **) Postal Code (required only for US and Canada)
  • Telephone [Area Code, Number, Ext., Country Code]
  • Facsimile [Area Code, Number, Ext., Country Code]
  • Email Address

Recall Contact

To automatically populate Recall Contact information with the information entered for the Most Responsible Individual, press the Populate Recall Contact button.

  • (*) Official's Name
  • Title
  • (*) Firm Name
  • (*) Address Line 1
  • Address Line 2
  • (*) City
  • (**) State/Province (required only for US and Canada)
  • (*) Country
  • (**) Postal Code (required only for US and Canada)
  • Telephone [Area Code, Number, Ext., Country Code]
  • Facsimile [Area Code, Number, Ext., Country Code]
  • Email Address

Buttons - BPD AI - Industry Recall Contacts Screen

  • Populate Recall Contact - Populates the Recall Contact section with the same information entered for the Most Responsible Individual
  • Previous - saves changes and navigates to the BPD AI - Distribution Pattern Information screen
  • Continue - saves changes and navigates to the BPD AI - Preview Report screen
  • Save - commits any changes to the database


Required Fields - designated by the symbol (*)
Conditionally Required Fields - designated by the symbol (**)

BPD AI - Preview Report Screen

Review the information on the Preview Report screen for accuracy.

  • If all information appears correct and complete, submit the BPD AI report by pressing the Submit To FDA button.
  • If any information is inaccurate, please navigate to the appropriate screen, make corrections, and then submit the report.

Buttons - BPD AI - Preview Report Screen

  • Previous - navigates to the BPD AI - Industry Recall Contacts screen
  • Submit to FDA -Submits the report to FDA and navigates to the BPD AI Submitted Report Screen.

BPD AI - Submitted Report Screen

The BPD AI Submitted Report screen is displayed as confirmation that the BPD AI record has been submitted to the FDA.

  • Please print a copy of this report for your records by using your web browsers PRINT function.
  • Please refer to the BPD Confirmation # in the event additional correspondence is needed.

Buttons - BPD AI - Submitted Report Screen

  • Select Establishment- Navigates to the Select Establishment screen
  • Unfinished Reports - Navigates to the Unfinished Reports screen

Problems?

BPD Reports

Contact information for questions concerning Biological Product and HCT/P Deviation Reports

If for any reason you are unable to utilize the online system, you may manually submit your Form FDA 3486 . If you need the form, you may download it from: http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3486.pdf.

After downloading the form, complete it by following the instructions, save it, print it out and return it to the following address:

Director, Office of Compliance and Biologics Quality (HFM-600)
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike, Suite 200N
Rockville, MD 20852-1448

BPD Additional Information (AI) Reports (for recall classification purposes)

If you need assistance you may contact CBER at 301-827-6201 or by email at CBER_RecallAlerts@fda.hhs.gov

If you need Adobe Acrobat Reader to read the PDF form you may download it from: http://get.adobe.com/reader/.

 
Updated: March 19, 2009