Contents

5.10 - REPORTING

5.10.1 - ESTABLISHMENT INSPECTION REPORT (EIR)

See IOM 1.1 English language requirement. The EIR consists of the following in this order: a printed copy of the FACTS Establishment Inspection Record (EI Record) including, at least, the endorsement with the EIR distribution printed at the bottom of the "endorsement" section of the EI Record; carbon or other copies of FDA forms issued during the inspection such as the FDA 482, FDA 483, and FDA 484; investigator's narrative report; copy of assignment if available; exhibits; and/or any additional material attached and referred to in the narrative report. Regarding the use of checklists (such as the BSE Checklist), the original raw data completed checklist should be submitted with the EIR. If you maintain the data in your diary, rather than entering directly on the form, then enter on the electronic copy. A printed copy from FACTS becomes the data to include with the EIR.

No copies of inspection reports will be maintained other than in headquarters, district, and resident post files. The signed original report is maintained in the district office or in the case of foreign inspections in the appropriate Center HQ office.

5.10.2 - ENDORSEMENT

The endorsement of the establishment inspection is prepared by the supervisor. Some supervisors may have the investigator prepare proposed endorsements. Endorsements should fit in the available space provided in FACTS. If the endorsement exceeds the 2000 character space provided in FACTS, a separate endorsement should be prepared, fully identifying the firm with a Summary of the Endorsement included in FACTS. The FACTS EI Record will be printed and used as the endorsement and routing document to accompany the EIR. See also IOM 5.10.4.1.

Normally the endorsement consists of:

1. The reason for the EI, i.e., workplan, or assignments from headquarters. State the subject of the assignment and reference. If the assignment was issued hard copy (i.e. not through FACTS), it should be attached to the EIR following the narrative. Include the FACTS assignment number and compliance tracking number if applicable.
2. A brief history of previous findings including classification of previous EI, any action taken by the district and/or corrective action taken by the firm in response to inspectional observations from the previous inspection.
3. A concise summary and evaluation of current findings and samples collected.
4. Refusals, voluntary corrections or promises made by the firm's management.
5. Classification and follow-up consistent with inspectional findings and Agency policy including notification of other districts and headquarters as warranted.
6. Distribution consistent with District policy and the requirements of the specific Compliance Program Guidance Manual(s).
7. Note: route a copy of the FACTS Establishment Inspection Record and the EIR to DIOP (HFC-170) when any violative, imported products are identified.
8. Per  CPG section 110.300, do not report the FURLS Registration number. 

The existence of Personal Safety Alerts (IOM 5.2.1.3) or Situational Plans (IOM 5.2.1.4) pertaining to the firm should be included in the endorsement section only and not in the EIR. The signed endorsement should be updated to indicate if an addendum to the EIR (IOM 5.10.6) or an amended FDA 483 (IOM 5.2.3.1.6.2) has occurred.

PROFILES: Updating the Field Accomplishments and Compliance Tracking System (FACTS) database with a Compliance Status for each profile class code associated with the firm's operations and/or products, is the responsibility of Field and Center Investigators, Supervisors and Compliance Officers. 

For Domestic inspections, hardcopy or e-mail notification of Potential OAIs are not necessary.  FACTS automatically sends OAI Notifications to DCIQA (HFC-240) electronically. 

For foreign inspections, the instructions in Exhibit 5-14, Updating Profile Data in FACTS-Guidance, states “When a potential OAI Notification cannot immediately be entered in the FACTS firm profile record, the investigator should notify the Division of Field Investigations (DFI) of the potential OAI situation via FAX (301-827-6685 or 301-443-6919) as soon as the potential OAI situation is known and during the investigation.  DFI will notify the appropriate Center and Division of Compliance Information and Quality Assurance (DCIQA) at 240-632-6824 or by e-mail to ORA HQ DCIQA Employees.”

See Exhibit 5-14.  The COMSTAT Guidance to Field and Centers document can be accessed from the DCIQA web site.

5.10.2.1 - Compliance Achievement Reporting System (CARS)

FACTS is used to report achieved and verified compliance actions, which are not the result of a legal action. A compliance achievement is the observed repair, modification, or adjustment of a violative condition, or the repair, modification, adjustment, relabeling, or destruction of a violative product when either the product or condition does not comply with the Acts enforced by the FDA.

5.10.2.1.1 - Reporting Criteria

There are three criteria for reporting into the CARS system:

1. The detection or identification of the problem. A problem may be observed by FDA, other federal officials, or by state or local authorities and referred to FDA; and as a result of an inspection, investigation, sample analysis, or detention accomplished by ORA or states under contract to ORA.
2. The correction of the problem. The correction is directly attributable to the efforts of ORA or state officials under contract to ORA (involving contract products only); and is unrelated to the filing of a legal action, i.e., seizure, prosecution, injunction.
3. The verification of the correction of the problem. The correction is verified by the FDA, other federal officials or state or local authorities and reported in writing to the FDA; and is based on an inspection, investigation, sample analysis, or letter from a firm to FDA certifying the problem has been corrected.

5.10.2.1.2 - Data Elements

Only when the corrective action(s) has been verified should a CARS be reported. The data elements are those entered/coded in FACTS (See IOM Exhibit 5-15):

1. PAC. See the Data Codes Manual. Should there be insufficient space to code all corrections verified on an occasion, record the most significant corrections.
2. PROBLEM TYPE. The problem type is the problem(s) identified during the operation(s). Use the List of Values (LOV) found in this field on the Compliance Achievement Reporting Screen. If  "Other" is chosen, you should include an explanation in the "Remarks" field.
3. CORRECTIVE ACTION. The action the establishment took to correct the identified problem. Use the LOVs found in this field on the CARS screen. If "Other" is selected, you should include an explanation in the "Remarks" field.
4. VERIFICATION DATE. Use the date the corrective action(s) is verified, either through an establishment inspection, an investigation, or a letter from the establishment certifying the corrections have been made. Include documentation to verify the action such as repair receipts/plans.
5. CORRECTING ORGANIZATION. The FDA, other federal agency, or state or local authority, which observed the verified correction. Use the LOVs found in this field on the CARS screen.
6. REPORTING DISTRICT. The FDA, other federal agency, or state or local authority, which is actually inputting the verified correction. Use the LOVs found in this field on the CARS screen.
7. REASON FOR CORRECTION. The action the FDA took to make the correction happen. Use the LOVs found in this field on the CARS screen. If "Other" is chosen, you should include an explanation in the "Remarks" field.

5.10.3 - FACTS ESTABLISHMENT INSPECTION RECORD (EI Record)

Instructions for completion of the FACTS (Field Activities and Compliance Tracking System) EI Record will be included in future revisions. Until such time consult with your supervisor and District Lead FACTS user(s). See IOM Exhibits 5-15 and 5-16. The FACTS Profile Data instructions and FACTS generated assignment are attached as IOM Exhibits 5-9 and 5-14.

Inspectional accountable time in FACTS consists of the hours devoted to file reviews (operational preparation), actual inspectional, investigational, audit, etc. time (onsite), document (exhibit) preparation and EIR (report) write-up. Accountable time does not include travel time. One occasional exception could be when more than one participant in an inspection/investigation travel together and discuss/prepare while in route.

5.10.4 - NARRATIVE REPORT

See IOM 1.1 English language requirement. You should use Turbo EIR for all EIRs.  The narrative report is the written portion of the EIR, which accurately describes the investigator's inspectional findings. The narrative report may be prepared in two formats depending on the type of inspection, inspection classification, and program area. A Summary of Findings narrative report is used for non-violative, non-initial inspections - see IOM 5.10.4.1. The full Standard narrative report is used for human drug and medical device inspections, initial and potential Official Action Indicated (OAI) classified inspections in other program areas - see IOM 5.10.4.3. The "Summary of Findings" report format may be used for some Voluntary Action Indicated (VAI) classified inspections as directed by your supervisor. Additional requirements for human drug and medical device reports are described in IOM 5.5.8 and 5.6.9. For all reporting formats, include additional information as directed by your assignment, Compliance Program Guidance Manual, or your Supervisor.

All reports should be prepared as stand-alone documents outside of FACTS. Your Establishment Inspection Report (EIR) should:

1. Be factual, objective, and free of unsupportable conclusions.
2. Be concise while covering the necessary aspects of the inspection.
3. Not include opinions about administrative or regulatory follow-up.
4. Be written in the first person.
5. Be signed by all FDA and commissioned personnel participating in the inspection. See IOM section 5.1.2.5.1 when more than one FDA or commissioned person participated in the inspection.

5.10.4.1 - Non-Violative Establishments

5.10.4.2 - Violative Establishments

5.10.4.3 - Individual Narrative Headings

There are many acceptable ways of organizing a narrative report. The key is to cover the required information in IOM 5.10.4 and 5.10.4.2, or as required by the assignment, Compliance Program Guidance Manual, or your supervisor. The appropriate use of headings should not result in repetition of the same information in different sections. You are encouraged to create headings as necessary to present the inspectional findings in the most concise manner. For non-violative and some VAI reports, a single heading such as “Summary of Findings” is sufficient (for exceptions, see IOM 5.10.4.1).  Turbo EIR should be used to generate the FDA 483. In certain instances, if you experience computer problems, do not delay the issuance of the FDA 483.  See IOM 5.2.3. You should use Turbo EIR for all EIRs.

5.10.4.3.1 - STANDARD NARRATIVE REPORT

STANDARD NARRATIVE REPORT: HEADINGS, CONTENT AND ARRANGEMENT OF YOUR REPORT

Use the Standard narrative report format for all program areas. The Standard narrative format contains sections within specific headings. Reporting requirements under these headings fall into two categories: those which should be reported every time (if applicable) and those which only need to be reported if an element has changed. 

Initial or potential OAI classified inspections: complete a full standard narrative report for all program areas. You should include a Table of Contents for all complex or full standard narrative reports.

Note: All human drug and medical device inspection reports should be full narrative Reports. You should add the supplemental information listed under the subheadings for human drug and medical device inspection reports as appropriate. Human drug inspection reports do not need full and detailed narratives for every heading. In many cases, brief summaries addressing the format areas will be sufficient.

5.10.4.3.2 - Summary

Summary:

1. Provide the reason for the inspection (e.g., compliance program, by assignment, etc.);
2. The scope of the inspection (comprehensive, directed, sample collection only, QSIT level, etc.).
3. Provide a summary of the findings, date, and classification of the previous inspection and the firm’s response/corrective actions.
4. List the products, systems and processes covered during the current inspection, and the types of records and documents reviewed. For human drug reports, list the systems not covered.
5. Provide a summary of the current findings, refusals, samples collected, warnings given to management, and a summary of management's response or voluntary corrections.
6. Per  CPG section 110.300, do not report the FURLS Registration number. 

5.10.4.3.3 - Administrative Data

Administrative Data:

1. The firm name, address, phone, FAX and e-mail address.
2. Report the names and titles of the Investigator(s), Analyst(s), non-FDA officials, etc.  Report the name of the firm’s responsible official who gave permission to non-FDA officials without inspection authority to accompany you during your inspection.  See IOM 5.1.1 and 5.2.2.
3. The inclusive date(s) of the current inspection, i.e., list the actual dates in the plant.
4. If a team inspection and some individuals were not present during the entire inspection, indicate dates in plant for each team member.

Report Full Names and Titles of:

1. To whom FDA Official Credentials were shown,
2. To whom any FDA forms were issued to or signed by during the inspection (FDA 482, 483, 484, 463, etc.); where appropriate, explain the reason a form(s) was not issued to or signed by the most responsible individual (this may be reported in the Individual Responsibility and Persons Interviewed heading below),
3. Who wrote which section of the EIR, if this was a team inspection report, and
4. In-plant inspectors or other government agencies (IOM 5.4.9).

5.10.4.3.4 - History

History:

1. Report the legal status of the firm (corporation, partnership, limited liability corporation, etc.). If a corporation, list in which state and when the firm was incorporated.
2. List the parent corporation, corporate address and any subsidiaries.
3. Provide a summary of any regulatory actions and prior warnings (do not cite any action only recommended but not approved). You should also report any significant/relevant inspectional history pertinent to the current EI or recommendation.
4. Include any relevant recalls, etc. since the last inspection.
5. Report the hours of operation and any changes from past inspections (include seasonal variations).
6. Report the current registration(s) status or any changes to registration status. Per CPG section 110.300, do not report the FURLS Registration number. 
7. If directions to the firm would be helpful in future visits, include the information.
8. Provide the names, titles and addresses of top management official(s) to whom correspondence should be addressed (FMD 145, W/L, etc.).
9. For foreign inspections, list U.S. consignees to whom the firm’s products are shipped.
10. For Human Drugs - domestic firms, identify the general types of customers and provide the names and addresses for several regular customers of a few of the firm’s products.

5.10.4.3.5 - Interstate (I.S.) Commerce

Interstate (I.S.) Commerce:

1. Report changes in the previous estimate of the percentage of products shipped outside of the state (or exported to the U.S.) and the basis of the estimate.
2. Report the firm's general promotion and distribution patterns.
3. If there is an apparent violative product, provide examples of I.S. shipments of violative product(s); or
4. If no such shipments, provide examples of I.S. shipments of major components of apparent violative products - with complete I.S. documentation in either case.

5.10.4.3.6 - Jurisdiction (Products Manufactured and/or Distributed)

Jurisdiction (Products Manufactured and/or Distributed):

1. Include a list of a representative number of currently marketed products subject to FD&C Act or other statute enforced by FDA or counterpart state agency, including any believed violative.
2. Collect appropriate labeling (product and case labels, inserts, brochures, manuals, promotional materials of any type) for those products believed violative or representing any significant new or unusual operation, industry or technology; or as directed by your supervisor.
3. Document any applicable labeling agreements (and obtain a copy) and statutory guaranty given or received per Sections 301(h) and 303(c)(2) of the FD&C Act [21 U.S.C. 321 (h) and 333 (c)(2)] (IOM 5.3.7.2)

In addition, the label, labeling and promotional materials are a critical part of determining a product’s intended use.

1. In instances where a regulatory action is being considered based on product labels, labeling, and/or other promotional materials, including any Internet websites, you should collect all available documentation. This includes all written, printed or graphic matter on the immediate container of an article or accompanying the article (the product’s label and labeling, see FD&C Act, 201(k) and (m) [21 U.S.C. 321(k) and (m)] and IOM 4.4.9.1). Accompanying labeling could include brochures, pamphlets, circulars, and flyers, as well as audio and video tapes.
2. In cases where there may be a dispute about whether a product is a drug or a dietary supplement, you should collect all materials which claim a product can be used for the treatment of any disease.

5.10.4.3.7 - Individual Responsibility and Persons Interviewed

Report with whom you dealt, and in what regard (both during and prior to the start of the inspection):

1. Who provided relevant information,
2. Who accompanied you during the inspection,
3. Who refused access to required records or any other refusal of information (Note: a separate heading for Refusals may be needed if refusals are significant, extensive or an Inspection Warrant is anticipated),
4. Who refused to permit inspection (IOM 5.2.5.1) and
5. For Human Drug inspection reports, also include the name, title, physical mailing address, phone, and fax number and e-mail address for any U.S. Agent or broker who represents the company when dealing with the FDA.

Describe roles and authorities of responsible individuals, including the full names and titles of individuals providing you with information.

Report changes to the following:

1. Who is the most responsible individual at the inspected firm?  Who is the responsible head or designated correspondent?  Refer to IOM 5.3.6, 5.3.6.1, and 5.3.6.2 
2. Report full names and titles of owners, partners, and corporate officers. Who has the duty, power and responsibility, and authority to prevent, detect, and correct violation(s), and how is this demonstrated and/or documented? See IOM 5.3.6.2 
3. Report the chain of command; include an organizational chart (create if necessary).
4. Obtain a copy of public annual report, if any.
5. List the names and titles of key operating personnel.

5.10.4.3.8 - Firm's Training Program

The firm's training programs are of particular significance where inspectional findings find people may not be adequately trained.

5.10.4.3.9 - Manufacturing/Design Operations

Manufacturing/Design Operations:

1. Report only changes to the firm's general overall operations, including significant changes in equipment, processes, or products since the previous inspection. Include schematics, flow plans, photographs, formulations and diagrams, if useful.
2. List names and sources of new or unusual components or raw materials.
3. Report equipment considered new or unusual unless otherwise directed.
4. Submit pertinent formulas (especially those being manufactured during your inspection) and processing instructions with labeling of suspect products.

For human drug inspection reports:

This section of the EIR should be organized by system covered during the EI as outlined in CPGM 7356.002. In each section, include a brief summary of what you reviewed in order to meet the key system element outlined in the CPGM. You should add more detail for the system elements found to be deficient, or the subject of a FDA 483 observation.

For medical device inspection reports:

1. Describe manufacturing operations by sub system covered in your inspection (Management Controls, Design Controls, Production and Process Controls, Corrective and Preventive Action Controls, Material Controls, Facility and Equipment Controls, and Records/Documents/Change Controls). For ALL Level 2, 3, and "for cause" inspections: for production and process controls - indicate which production processes were covered/reviewed. If a subsystem was not specifically covered during your EI, you do not need to separately describe the general operations of that subsystem.
2. For all inspections covering CAPA - indicate which data sources were available for review and which were actually reviewed; include a brief statement regarding coverage or non-coverage of applicable tracking requirements, MDRs, sterilization, and reports of corrections and removals.
3. If the Design Control system was covered, indicate the design project(s) covered during the inspection. Where design activities occur at a location other than the manufacturing site, list the name, address of the design location and responsibilities of those performing the design activities.
4. If applicable, identify the name and address of the specification developer if different from either the manufacturing site or where design activities occur.  

5.10.4.3.10 - Manufacturing Codes

Manufacturing Codes

1. If the manufacturing codes are unchanged, include a statement in the EIR the system is the same as described in reports on file at the District.   Indicate the date of the EIR in which the codes are fully explained.
2. If the manufacturing codes have changed, describe the manufacturing coding system (lot, batch, product, etc.), and a key to interpretation of codes.
3. For medical device inspections reports: where appropriate, include a description of the system used to identify and maintain control of components during the manufacturing process, as well as, the codes used for traceability (for applicable finished devices).

5.10.4.3.11 - Complaints

Note: These complaints include those reported to the FDA by consumers, health care professionals, industry, etc.; and all complaints received by the firm.

1. Report your review of the firm’s complaint file(s).
2. In addition, if returned goods and/or documents for returned goods are examined, describe findings. If not examined, so indicate.
3. Report your follow-up of consumer/trade complaints, Adverse Event Reports, MDR's, MedWatch reports or recalls identified in the district factory jacket for coverage. Correlate consumer/trade complaints, Adverse Event Reports, MDR's, MedWatch reports to specific objectionable conditions observed.

5.10.4.3.12 - Recall Procedures

Describe plans and procedures for removing products from marketing channels if necessary.   If these procedures are in written SOP-type format, you may reference any copies obtained to aid in your explanation.

5.10.4.3.13 - Objectionable Conditions and Management's Response

If any observations were provided to management in writing (FDA 483) at the conclusion of the inspection list each observation and report each observation providing information organized under the two headings Supporting Evidence and Relevance, and Discussion with Management below.

NOTE: Observations of a verbal nature should be reported in sufficient detail under the General Discussion with Management (correlate any Exhibits, samples, etc. to any "verbal" observations).

5.10.4.3.13.1 - Supporting Evidence and Relevance

Sufficiently describe the observation as necessary to relate the facts as you found them.

1. Identify specific pages of exhibits and/or samples (e.g., procedure title, section, paragraph, sentence), labeling text, interstate shipping records which in your judgment document violations so supervisors, compliance officers, and other reviewers can readily evaluate your evidence.
2. Describe verbal statements (verbatim if possible) by firm officials having knowledge, duty, power, and responsibility to detect, prevent, or correct the apparent violation. 
3. Identify the responsible party for each apparent violation (i.e., if known.)
4. Identify which team member (if applicable) was responsible for the observation.
5. When appropriate explain how this observation relates to the overall situation; i.e., impact on the product, batches, or lots involved, and any relationship to other products, processes, or other FDA 483 observations.
6. The duration of the problem.

5.10.4.3.13.2 - Discussion with management

Discussion with management:

1. Report management's response to each specific observation, time frames given for corrections and/or corrective action. 
2. Report any disagreements with or refusals to correct the observation.

For medical device inspection reports:

1. For each observation based on sampling of records, indicate which Sample Table and level of confidence was used and the actual number of records sampled.
2. If the number sampled is different than the actual number reviewed, so indicate.

5.10.4.3.14 - Refusals

Provide full details of all refusals of/for requested information, statutory information, photography, entry, etc. received during the inspection, including who made the refusal and, if available, why the refusal was given.

5.10.4.3.15 - General Discussion with Management

General Discussion with Management:

1. Report the names and titles of all present, including those present via electronic media (describe).
2. Include the name and title to whom the FDA 483 was issued.
3. Provide additional discussion items not provided in writing at the conclusion of the inspection, such as: questionable labels, labeling and/or labeling practices, commercialization of products covered by IDE or IND, fraudulent health claims, registration/listing deviations, lack of approved PMA, 510(k), NDA, ANDA, etc. These include all verbal observations deemed not to merit inclusion on the FDA 483 (IOM 5.2.3)
4. A description of each warning, recommendation, or suggestion given to the firm, and to whom given.
5. Management's general responses to the inspection and/or to groups of items listed on the report of observations or discussed at the conclusion of the inspection.

5.10.4.3.16 - Additional Information

Report changes as appropriate.

1. Describe contractors used and for what purpose. For Medical Device inspection reports: also include names and addresses of all applicable third party installers or servicing organizations used by the manufacturer. Include their responsibilities.
2. Describe suppliers (major raw material, active ingredient, etc.) used and for what.
3. During inspections, when violative products imported into the U.S. or intended to be imported into the U.S. are encountered, document the product and foreign manufacturer in the EIR. Violative products could be rejected APIs due to non-conformance with the USP, foods without appropriate labeling, etc.   Send a copy of the EIR to DIOP (HFC-170). See IOM 5.2.1 and 5.10.2.
4. For initial inspections, verify distribution patterns for the firm’s products, raw materials, and components to firms which warehouse or further process products which may be subject to FDA regulations. Districts should incorporate information obtained into their Official Establishment Inventory improvement activities and complete form  FDA 457, Product/Establishment Surveillance Report as appropriate. See  IOM 8.6.2.
5. Report pertinent facts, which do not fit another section of the EIR. (For firms located in foreign countries, include information relative to lodging and travel; for domestic firms, include information relative to location of firm if difficult to find; etc.).

For human drug inspection reports - PDMA Coverage:

1. Describe what sample loss, theft, or diversion reports were covered during the inspection.
2. Describe the firm's sample audit and security systems, including a review of the firm's SOP's. Significant problems which may contribute to the firm's inability to adequately monitor sample distribution via sales representative, mail or common carrier should be addressed under objectionable conditions.

5.10.4.3.17 - Samples Collected

List and describe samples collected during the inspection.

5.10.4.3.18 - Voluntary Corrections

Voluntary Corrections:

1. Provide a brief description of improvements initiated by the firm in response to a previous inspection, report of observations and/or a warning letter.
2. Report voluntary destructions, recalls, and similar actions since the prior inspection or during this inspection.
3. Report any follow-up to recalls identified during the inspection (may be by referencing Attachment B recall report).
4. Include recalls to specific objectionable conditions observed.
5. Provide the identity of person(s) responsible for the corrections.
6. Report any appropriate voluntary corrections in FACTS CARS. 

5.10.4.3.19 - Exhibits Collected

List all exhibits attached. See IOM 5.10.5, Exhibits.

Briefly, describe or title each exhibit and sample number attached. You should include in your description the number of pages for each Exhibit listing.

NOTE: For complex inspections a cross-reference from the FDA 483 and verbal observations to applicable exhibits and samples can be useful during further review.

5.10.4.3.20 - Attachments

0Attachments as referred to here are any material attached to and referred to in the EIR, which are not evidentiary in nature; such as assignments, Center provided protocols, etc. See IOM 5.3.8.2 for identification of non-evidentiary material attached to the EIR. Documents attached to the EIR may be referred to in the EIR and listed here, such as the FDA 482, FDA 483, copy of the FDA 463a, etc. (in form number order); but such documents/forms may not be numbered, altered from their issued state, bear adhesive identification labels, etc. See the opening sentence of IOM 5.10.5. List and attach copies of associated reports (Recall Attachment B Report, etc.).

5.10.4.3.21 - Signature

All participants will sign the final narrative portion of the EIR. The prescribed format is to type each persons name, title, and district (or other affiliation) below the signature. In some cases immediate signature by all participants is not possible. An example as to how this can be accomplished is to forward an electronic "draft" copy of the EIR for all to read and approve, then followed or accompanied by the original signature sheet. When signed, return to the lead investigator for proper filing and routing. When using this method, a photocopy of the original signature page is made with the lead investigator's signature and temporarily attached to the EIR.

5.10.5 - EXHIBITS

Exhibits are materials collected from the firm and do not include FDA forms or copies of assignments. Exhibits should contribute to the objective of the assignment and the clarity of the report. They may include flow-plans, schematics, layouts, etc. If the materials collected from the firm are not needed as exhibits, they should be destroyed in accordance with district policy. Submit at least three copies of new or suspect labeling or other material collected as exhibits for labeling purposes. See IOM 4.4.9 for exceptions. These should be mounted in a manner so complete sets are submitted that can be reviewed by individuals in separate offices, i.e., labels 1-10 in each of three sets. You should identify records/exhibits submitted with an EIR using at least the Exhibits' number, firm name, date(s) of the inspection, and your initials. See IOM 5.3.8.2.

5.10.5.1 - Electronic information

Electronic information, databases or summary data from databases may be obtained from firms and evaluated during the course of an EI. This data may form the basis for observations or information included in the EIR. It is preferable to include a printed version and/or a summary of the data as an exhibit. When it is included as an exhibit to the EIR, it should be stored so as to protect the integrity of the data. See IOM 5.3.8.3.2 for procedures for collecting and identifying electronic data. Electronic media should be protected from extreme temperatures and most magnetic fields. Additional precautions may be necessary and you should be guided by your district procedures for storage of electronic data.

5.10.6 - ADDENDUM TO EIR

If your EIR requires correcting or clarification after it has been finalized, signed and distributed, you should prepare an addendum, with your supervisor's approval. The addendum should clearly identify itself with the EIR being added to, explain the necessity for the addendum, and clearly define what section(s) and page(s) are being revised. The addendum will be signed by the preparer.

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