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
212 3rd Ave. South
Minneapolis, MN 55401
(612) 334-4100 Fax: (612) 334-4134
|
DATE(S)
OF INSPECTION
7/22/2005 – 08/25/2005*
|
FEI
NUMBER
3002095335 |
NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED
TO: Aaron
P. Milton, Vice President Operations |
FIRM
NAME
Boston Scientific Scimed
|
STREET
ADDRESS
1 Scimed Pl |
CITY,
STATE AND ZIP CODE
Maple Grove, MN 55311-1565
|
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 may have caused or contributed to a death
or serious injury.
Specifically, from January 2004 to June 2005, 66 MDR reports of
death or serious injury were not submitted within 30 days.
——
Annotation: Promised to correct.
|
| OBSERVATION 2 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, from January 2004 to June 2005, 36 MDR reports of
malfunction were not submitted within 30 days.
——
Annotation: Promised to correct.
|
| OBSERVATION 3 Complaints representing
events that are MDR reportable were not promptly reviewed, evaluated,
and investigated by a designated individual.
Specifically, complaints of serious injury, death, or malfunction
were not always evaluated with regard to the prompt filing ofMDR
reports. From January 2004 to June 2005, as a result of human error,
46 events were filed late as MDR reports.
——
Annotation: Promised to correct.
|
| OBSERVATION 4 The procedures for implementing
corrective and preventive actions were not implemented.
Specifically, a corrective and preventive action was not initiated
on the recurring situation of MDR reports being submitted late.
——
Annotation: Promised to correct.
|
| OBSERVATION 5 Procedures for acceptance
or rejection of finished device production runs, lots, or batches
were not complete.
Specifically, the Relative Humidity specification range at [text
redacted] is established more broadly ([text redacted] RH) than
the actual applied process range (approximately [text redacted]
RH). Procedures do not describe steps to take, should this parameter
change from the routinely applied range.
——
Annotation: Under consideration.
|
| * DATES OF INSPECTION
07/22/2005(Fri), 07/25/2005(Mon), 07/26/2005(Tue), 07/27/2005(Wed),
07/28/2005(Thu), 07/29/2005(Fri), 08/01/2005(Mon), 08/02/2005(Tue),
08/03/2005(Wed), 08/04/2005(Thu), 08/08/2005(Mon), 08/09/2005(Tue),
08/11/2005(Thu), 08/23/2005(Tue), 08/25/2005(Thu)
|
| FDA EMPLOYEE'S NAME, TITLE, AND SIGNATURE:
[Handwritten Signature]
Jocelyn M. Muggli, Investigator
[Handwritten Signature]
Ralph W. Jerndal, Investigator
[Handwritten Signature]
Billi Jo M. Johnson, Investigator |
SEE
REVERSE
OF THIS
PAGE |
|
|
DATE
ISSUED 08/25/2005 |
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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