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Boston Scientific Scimed, Maple Grove, MN, 483 dated 07/22/2005 - 08/25/2005

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 letter is available in PDF at the bottom of this page.

 
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:

SEE REVERSE OF THIS PAGE

[Handwritten Signature]
Jocelyn M. Muggli, Investigator
Ralph W. Jerndal, Investigator
Billi Jo M. Johnson, Investigator

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:

  1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or
  2. 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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