Note: Although this FDA-483 is an
accurate representation of the original FDA-483 issued to the firm, it is not an exact
copy. Slight modifications to the original FDA-483 have been made to accommodate its
conversion to the HTML format. A scanned copy of the original FDA-483 is available in PDF format on this website. |
DEPARTMENT
OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION |
DISTRICT
OFFICE ADDRESS AND PHONE NUMBER One
Montvale Avenue
Stoneham, MA 02180
(781) 596-7700 Fax:(781) 596-7896
|
DATE(S)
OF INSPECTION 03/28/2005 - 05/20/2005* |
FEI
NUMBER 3001451463 |
NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED
TO: Paul
W. Warren, General Manager |
FIRM
NAME
Boston Scientific Corporation |
STREET
ADDRESS
500 Commander Shea Blvd. |
CITY,
STATE AND ZIP CODE
Quincy, MA 02171-1518 |
TYPE
OF ESTABLISHMENT INSPECTED
Distributor, Manufacturer, Sterilizer |
This document lists
observations made by the FDA representative(s) during the inspection
of your facility. They are inspectional observations, and do not
represent a final Agency determination regarding your compliance.
If you have an objection regarding an observation, or have implemented,
or plan to implement, corrective action in response to an observation,
you may discuss the objection or action with the FDA representative(s)
during the inspection or submit this information to FDA at the address
above. If you have any questions, please contact FDA at the phone
number and address above. |
The observations
noted in this Form FDA-483 are not an exhaustive listing of objectionable
conditions. Under the law, your firm is responsible for conducting
internal self-audits to identify and correct any and all violations
of the quality system requirements. |
DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:
OBSERVATION 1
The organization structure is not adequate to assure that quality
system requirements are fully met.
Specifically, activities for the sale, shipment, receipt, control,
and return of inventory are not adequately controlled through personnel
actions, documentation, and associated procedures. |
OBSERVATION 2
Products that do not conform to specifications are not adequately
controlled.
Specifically:
- [REDACTED] units of Taxus Express
2 (Material Number [REDACTED], Batch [REDACTED])
were shipped to [REDACTED] different customers
direct from BSC Quincy, while on "Pending KDR Test Results" ship
hold. The Taxus Express 2 units had failed initial KDR
(Kinetic Drug Release) testing.
[REDACTED 5 lines]
- Three shipments of 45-233, Vaxcel Low Profile
Ports, were made after the ship hold was received in this facility
in Quincy, MA on 8/25/04. The sales reps were notified
by BSC Quincy on 8/26/04. Products were either sold or
provided as samples by the sales reps on 9/21/04, 12/14/04, and
2/15/2005. They
include:
[REDACTED 3 lines]
- [REDACTED] batches
of Symmetry product (i.e. Balloon Dilatation Catheter) from Sterilization
load 0600006201 were released by BSC Quincy and shipped in September
and October 2004 to BSC customers. BSC Quincy received
partial release paperwork on 8/24, 9/3, and 9/8/2005 from BSC
Galway releasing particular batches from specific delivery numbers
from this sterilization load. However, Galway had not
released these particular batches due to a PRR, Product Review
Request, investigation being open for the Symmetry products. This
PRR was closed 2/8/2005. There
is no documentation of the [REDACTED] batches
ever being released by Galway. At least [REDACTED] units
from these [REDACTED] batches have been distributed.
|
OBSERVATION 3
There is no documentation of the disposition of nonconforming
product.
Specifically, BSC Quincy closed ship hold 04-08-018 on 1/18/05
at their facility without accounting for the sales rep stock that
was being returned to Quincy. The disposition of the product
for hold 04-08-018 on the Notification of Shipping Hold Release
dated 12/22/04 did not include "Sales Rep Inventory" a.k.a.
Trunk Stock, when it was included on the original hold. The
Quincy facility takes the orders from the sales reps, sends them
product, tells them if there is a shipping hold, what to return
via reservation number, and keeps track of the sales rep stock.
——
Annotation: Promised to correct. |
OBSERVATION 4
Corrective and preventive action activities have not been documented,
including investigations of causes of nonconformities, the actions
needed to correct or prevent recurrence of nonconforming product
and other quality problems, and implementation of corrective and
preventive actions.
Specifically:
- The following CAPAs did not include the necessary
details to document the entire non-conforming condition:
- CAR 05-004, involving the shipment of [REDACTED] units
of Taxus Express 2, which had failed initial KDR testing, did
not include the actual occurrence dates, what actually happened
(including the 3 other mistaken batch removals that were caught
and put back into their original locations), and who was involved
in the incident.
- CAR 04-052, involving transaction of ship
hold product into finished goods, did not include the number
of orders and units shipped.
- CAR 04-082, involving a product that was
placed on ship hold, which BSC Quincy attempted to retrieve
before leaving the facility, did not include the fact that
the shipment was pulled back, had portions of the shipment
replaced, and was refilled with product in inventory that
was also on hold.
- CAR 04-120, involving demo product being
returned, labeled not for human use, placed back into finished
goods, and sold, did not list the product or quantity.
- CAR 05-013, involving release of product
before LAL testing was completed, did not state in the CAPA form
what product this CAPA involved.
The local CAPA procedure, S842393-00, Rev. AU, states that: "The
CAPA administrator will complete the first section of the form … A
detailed description of the Nonconformance, Potential Nonconformance,
Preventive Action, or Action Item."
- Not all e-mails of discussions and decisions
made regarding CAPAs and PIRs were kept with the respective files.
- CAR 04-120 did not include the e-mail regarding
the investigation.
- CAR 04-125 did not include the e-mail regarding
future release of Symmetry products.
- PIR USD-2005-01-01 did not completely describe the events
that occurred. It states only that several batches were inappropriately
removed from the Quarantine location. The quantity and
batch numbers that were mistakenly removed, which were caught
and returned to their original locations, were not documented.
The PIR procedures state that the owner of the PIR will verify
that the PIR is accurate.
- PIR USD 2004-10-02 does not include any documentation
of verbal discussions between Galway and Quincy about the status
of the product released prior to a recommendation made on 2/28/05
not to conduct a field action.
——
Annotation: Under consideration.
|
OBSERVATION 5
The procedures addressing identification of corrective and preventive
actions were not implemented.
Specifically, PIR USD 2005-01-01, Part IIIA, Global Medical/Clinical
Assessment, did not answer the question from the Detection section appropriately. This
section questions the physician's ability to detect a problem with a
device. The rationale provided addresses the firm's ability to
detect outliers before distribution.
The PIR procedures state that the owner of the PIR will verify that
the PIR is accurate.
——
Annotation: Promised to correct within 30 days.
|
OBSERVATION 6
Changes in methods and procedures needed to correct and prevent identified
quality problems are not implemented and effective.
Specifically, there have been multiple instances of shipments of product
on hold to BSC customers, although these individual CARs have
been verified for effectivity. Review of the 2004 and 2005 Corrective/Preventive
Action Logs reveals at least 4 instances of shipments of products on
hold: CAR 05-017, 05-004, 04-125, and 04-052.
The local CAPA procedure states "the corrective or preventative
actions are verified and reviewed to ensure all actions taken have been
effective." It also states that the CAPA file will consist
of "evidence of implentation and evidence of verification and effectivity."
|
OBSERVATION 7
Records of changes did not include a description of the change, the
signature of the approving official(s), and the approval date.
Specifically:
- PIR USD-2005-01-01 had 3 pages which included Part
IV: PIR Team Input Approval and Part V: Recommendation for Field Action
Approval.
- The original, which had section IV on page 8 of 10,
includes printed titles and names for the 3 approving officials as well
as the owner's original signature. The other 2 pages including
this particular section are on page 9 of 11. These pages,
which show the other 2 approving officials signatures, do not
have the printed names and titles for all 3 approving officials.
- The original, in Section V, includes a check in the
YES block for field action recommendation. The other 2 copies
of this page do not have this block checked.
Regarding these discrepencies, the owner, who is the Director
of Quality Assurance, stated that she probably updated and reprinted
an original prior to her signing the document.
- A training record was altered for employee, [REDACTED],
from April 29, 2005, when first collected. On May 11, 2005, it
was reviewed again, and it was noted that "TD" was added
to some of the training boxes without explanation.
- PIR USD-2005-01-01 had 2 original pages 9 of 10. The
first page 9 of 10 includes original handwritten statements stating
to see attached documents. The second page 9 of 10 includes
an original signature of the FAC chairperson.
——
Annotation: Promised to correct.
|
OBSERVATION 8
Procedures for the control and distribution of finished devices have
not been complete and implemented to ensure that only devices approved
for release are distributed.
Specifically, a sales rep (M003) was not notified when a hold (#04-08-018) was
received by BSC the same day the product was sent to M003. The
list the firm uses to call the sales reps the following day includes
sales reps who have received the product but not the sales reps who
have been sold the product.
SOP BSC Rep Stock Ship Hold/Release Procedure, 90147555, Rev. AA, addresses
only the product that the sales reps have received, but not product
that they have been sold. This procedure states only to "Periodically
check on RGA's (Return Goods Authorization) to see if closed." The
procedures are not complete for regularly notifying sales reps, when
they still have a ship hold product in their possession that was not
returned.
In addition after a ship hold release form is received, the procedure
allows the sales support staff to inform the sales reps that the RGA's
are cancelled. This allows the ship hold to be released without
the sales reps actually returning affected product.
——
Annotation: Promised to correct.
|
OBSERVATION 9
The acceptance status of product was not clearly identified.
Specifically:
- Not all sales reps are notified when they sell product
that is currently on hold. BSC does not have a procedure to
notify sales reps when they have sold product that is on ship hold.
- BSC had 9 Shipping holds not signed by an employee in
the Quality Department in BSC Quincy upon arrival of the holds
at the firm. The W1 Quincy Trans Shipping Hold procedures, S800294-01,
Rev. AP and AN, both state that "a representative of the
QA group will review the form and sign the Shipping hold form whether
or not the form is signed from the intiating site." It
does not state that only shipping holds for Quincy will be signed. The
QA group checks the SAP computer system for all holds that arrive
at [REDACTED]. The
nine shipping holds that were not signed include:
- 04-08-009
Amendment dated 9/23/04 [REDACTED]
- 05-02-007 dated 2/9/05 [REDACTED]
- 05-02-018 Amendment dated 3/22/05 [REDACTED]
- 05-02-018 Amendment dated 3/16/05 [REDACTED]
- 05-02-018 Amendment dated 2/24/05 [REDACTED]
- 05-02-018 dated 2/23/05 [REDACTED]
- 05-03-006 dated 3/3/05 [REDACTED]
- 05-03-017 dated 3/17/05 [REDACTED]
- 05-03-018 dated 3/22/05 [REDACTED]
[REDACTED] Shipping Hold, S800294-01, Rev. AP,
states that a representative of the QA group will review the form
and sign the shipping hold form.
——
Annotation: Promised to correct.- Part A; Reported Corrected,
Not Verified - Part B
|
OBSERVATION 10
The corrective and preventive action procedures addressing the investigation
of the cause of nonconformities relating to product, processes, and
the quality system were not implemented.
Specifically, copies were not maintained of complete copies of PIRs,
which were used to obtain approval signatures. Only signature
pages were retained. The signature pages were attached as faxed
documents or e-mailed documents. They did not always print out
in the same format as the original PIR.
The local and corporate PIR procedures state the PIR shall be filed
in its local CAPA file with all other documents generated in the course
of generating the PIR and obtaining approval.
——
Annotation: Promised to correct. |
OBSERVATION 11
Required records are not retained for at least 2 years from the date
of release of the device for commercial distribution.
Specifically, the Emergency FREP Pull Lists, otherwise known as the
ZV29 Forms, are discarded. These forms document the physical
movement of finished goods and show who entered them into the SAP computer
system.
——
Annotation: Under consideration. |
OBSERVATION 12
Employees have not been adequately trained.
Specifically, the training file for a Distribution Associate/Overstock
and Replenishment employee [REDACTED] does not show
adequate documentation of training on procedures relating to everyday
job duties. The training file shows that [REDACTED] was
trained on S808448-01, Put Away Procedure, as a corrective action to
CAR 05-004, only on the day his employment was terminated.
——
Annotation: Under consideration. |
OBSERVATION 13
Employee training is not fully documented.
Specifically, there is no documentation of sales reps attending an
overview of the BSC Quincy facility and its functions at BSC Quincy. This
overview includes a presentation and handouts, including the BSC Sales
Rep Stock Guidelines, covering inventory maximums, how to order, return,
and handle recalled products, and what SAP functions are.
——
Annotation: Under consideration. |
OBSERVATION 14
Corrective and preventive actions have not been verified or validated
to ensure that the action is effective and does not adversely affect
the finished device.
Specifically, CAR 05-013 did not update the procedure "Processing
of Sterile Finished Goods [REDACTED] Sterilized," 6000019-05,
Rev. AR. The non-conformance involved product which had [REDACTED] sterilized. The
corrective action plan states to update the procedure 6000019-01, which
referred to [REDACTED] processed products. Procedure
6000019-05, which refers [REDACTED] processed products,
has not been updated. The CAPA verification was completed on 3/18/05.
——
Annotation: Reported corrected, not verified. |
OBSERVATION 15
Quality audits did not verify that the quality system is effective
in fulfilling your quality system objectives.
Specifically, BSC did not record the number of ship holds reviewed
during the audits for 2004 and 2003. The Internal Audit procedure,
S808614-01, states the audit report will be formatted to include audit
scope - detailing procedures and documents reviewed.
——
Annotation: Promised to correct. |
* DATES OF INSPECTION
03/28/2005(Mon), 03/29/2005(Tue), 03/31/2005(Thu), 04/01/2005(Fri),
04/04/2005(Mon), 04/06/2005(Wed), 04/08/2005(Fri), 04/13/2005(Wed),
04/15/2005(Fri), 04/19/2005(Tue), 04/21/2005(Thu), 04/22/2005(Fri),
04/26/2005(Tue), 04/27/2005(Wed), 04/28/2005(Thu), 04/29/2005(Fri),
05/03/2005(Tue), 05/04/2005(Wed), 05/10/2005(Tue), 05/11/2005(Wed),
05/12/2005(Thu), 05/13/2005(Fri), 05/20/2005(Fri) |
FDA EMPLOYEE'S NAME, TITLE, AND SIGNATURE:
[Handwritten Signature]
Carla C. Cummins, Investigator
[Handwritten Signature]
Elizabeth B. Griffin, Investigator
Darin S. Wiegers, Investigator |
SEE
REVERSE
OF THIS
PAGE |
|
|
DATE
ISSUED 05/20/2005 |
FORM FDA 483 (7/00) PREVIOUS EDITION OBSOLETE
INSPECTIONAL OBSERVATIONS
Reverse Text on Page: The observations of objectional conditions and practices listed
on the front of this form are reported:
- Pursuant to Section 704(b) of the Federal Food, Drug and
Cosmetic Act, or
- To assist firms inspected in complying with the Acts and
regulations enforced by the Food and Drug Administration.
|
Section 704(b) of the Federal Food, Drug, and Cosmetic
Act (21 USC374(b)) provides: “Upon
completion of any such inspection of a factory, warehouse, consulting laboratory, or other
establishment, and prior to leaving the premises, the officer or employee making the
inspection shall give to the owner, operator, or agent in charge a report in writing
setting forth any conditions or practices observed by him which, in his judgement,
indicate that any food, drug, device, cosmetic in such establishment (1) consists in whole
or in part of any filthy, putrid, or decomposed substance or (2) has been prepared,
packed, or held under insanitary conditions whereby it may have become contaminated with
filth, or whereby it may have been rendered injurious to health. A copy of such report
shall be sent promptly to the Secretary.” |
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