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
300 River Place, Suite 5900
Detroit, MI 48207
(313) 393-8100 Fax:(313) 393-8139
|
DATE(S)
OF INSPECTION 08/25/2005 -
09/12/2005* |
FEI
NUMBER 1828132 |
NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED
TO: Mr.
George Telthorst, General Manager |
FIRM
NAME
Boston Scientific Corp |
STREET
ADDRESS
780 Brookside Dr |
CITY,
STATE AND ZIP CODE
Spencer, IN 47460-1080 |
TYPE
OF ESTABLISHMENT INSPECTED
Medical Device Manufacturer
|
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 I OBSERVED:
OBSERVATION 1
An MDR report was not submitted within 30 days of receiving or
otherwise becoming aware of information that reasonably suggests
that a marketed device has malfunctioned and would be likely to
cause or contribute to a death or serious injury if the malfunction
were to recur.
Specifically, Complaints are received by the Boston Scientific
Complaint Call Center, who then forwards the complaint to the appropriate
Complaint Management Center (CMC), where an initial MDR determination
is completed. The CMC then has the Complaint Investigation Site,
the site that manufactured the device, conduct a complaint investigation
to determine root cause and search for complaint trends. The following
complaints were determined to be MDR reportable by Boston Scientific
Corporation, however, the MDR reports were filed more than 30 days
after the initial complaint notification.
Complaint # |
Date |
MDR Date |
MDR # |
Total Days to Report |
656079 |
4/12/05 |
5/27/05 |
6000048-2005-00069 |
45 |
650818 |
12/9/05 |
1/28/05 |
6000048-2005-00011 |
50 |
658865 |
6/20/05 |
8/10/05 |
6000048-2005-00100 |
51 |
652641 |
1/31/05 |
7/25/05 |
6000043-2005-00028 |
176 |
655395 |
4/1/05 |
6/30/05 |
6000043-2005-00021 |
90 |
654226 |
2/28/05 |
6/30/05 |
6000043-2005-00020 |
122 |
646103 |
8/16/04 |
2/10/05 |
6000043-2005-00002 |
178 |
647525 |
9/21/04 |
2/10/05 |
6000043-2005-00008 |
142 |
645897 |
8/2/04 |
2/10/05 |
6000043-2005-00003 |
192 |
649232 |
11/1/04 |
1/28/05 |
6000048-2005-00013 |
91 |
655419 |
4/4/05 |
6/30/05 |
6000043-2005-00023 |
90 |
652411 |
1/25/05 |
3/21/05 |
6000043-2005-00014 |
55 |
646545 |
8/25/04 |
2/28/05 |
6000043-2005-00006 |
84 |
648630 |
10/18/04 |
2/28/05 |
6000043-2005-00005 |
41 |
647742 |
9/27/04 |
2/28/05 |
6000043-2005-00004 |
154 |
627223 |
5/7/05 |
6/30/05 |
6000043-2005-00022 |
54 |
|
OBSERVATION 2
Complaints involving the possible failure of a device to meet any
of its specifications were not evaluated and investigated where
necessary.
Specifically,
- The LeVeen Needle Electrode recall investigation was incomplete.
BSC Spencer, the manufacturer of the LeVeen Needle Electrode,
which is used as an accessory in conjunction with the Boston Scientific
Corporations Radiofrequency (RF) generator for thermal necrosis
of soft tissues, was not aware of the LeVeen Needle Electrode
recall when the FDA Investigator asked for that specific recall
documentation. By not being aware of the LeVeen Needle Electrode
recall and the subsequent investigation activities, the firm can
not assure that a complete recall investigation was conducted
on both the LeVeen Needle Electrode, manufactured at BSC Spencer,
and the BSC RF generator. The product investigation report is
WAT-2005-04-01. The LeVeen Needle Electrode affected model numbers
are M001262160 and M001262170.
- BSC Spencer has the capability to do trending analysis by product
lot number and product part number. For 7 of 15 complaints reviewed
specific to the Leveen Electrode recall, Part #M001262160 and
M001262170, Complaints 656988, 654015, 654019, 654023, 654029,
654032, 654033 the device was not returned and the complainant
did not give the lot number. The complaint investigation was incomplete
in that the firm did not investigate each complaint completely
to identify possible trends. For these seven complaints, the lot
number was not available and there was no trending analysis done
on the LeVeen product number.
|
OBSERVATION 3
Complaint handling procedures for reviewing and evaluating complaints
have not been completed.
Specifically, BSC Spencer External Customer Complaint Process procedure,
#90101079 is incomplete in that it does not identify all trending
types to be researched during the failure analysis to determine
if their are any related complaints. For 7 of 15 complaints reviewed
specific to the Leveen Electrode recall, the firm did not do trending
by product part number for complaint investigations when the device
was not returned and the firm was unable to obtain the product lot
number. The complaints were closed after 90 days. |
OBSERVATION 4
Procedures for the control and distribution of finished devices
have not been defined and complete to ensure that only devices approved
for release are distributed.
Specifically, when BSC Spencer places a shipping hold on products,
they can still ship product from their facility to the BSC Quincy
distribution facility "at risk" and on ship hold. The BSC Spencer
procedure, Shipping Holds - In-plant and Distribution Holds, Q489027-0A,
does not require the firm to hold product at the BSC Spencer facility.
|
* DATES OF INSPECTION
08/25/2005(Thu), 08/26/2005(Fri), 08/29/2005(Mon), 08/30/2005(Tue),
09/02/2005(Fri), 09/06/2005(Tue), 09/09/2005(Fri), 09/12/2005(Mon)
|
FDA EMPLOYEE'S NAME, TITLE, AND SIGNATURE:
[Handwritten Signature]
Benjamin J Smith, Investigator
|
SEE
REVERSE
OF THIS
PAGE |
|
|
DATE
ISSUED 09/12/2005 |
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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