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 12/15/2005 –
02/09/2006* |
FEI
NUMBER |
NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED
TO: Dale
W. DeVries, Vice President of Clinicals and Regulatory Affairs
|
FIRM
NAME
Guidant Corporation |
STREET
ADDRESS
4100 Hamline Avenue North
|
CITY,
STATE AND ZIP CODE
St. Paul, MN 55112 |
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 WEOBSERVED:
OBSERVATION 1
Not all of the actions needed to correct and prevent the recurrence
of nonconforming product and other quality problems have been identified.
Specifically, an analog to digital latching fault has been identified
in Prizm I, Prizm II and Vitality pulse generators that can result
in a loss of tachy therapy. There have been four confirmed and two
unconfirmed field events since 5/13/2002 for this cause. A software
fix was developed by 5/6/2004 (SCR #1883) to correct this fault
in the Renewal RF design project. However, a fix was not submitted
to FDA for certain affected preexisting devices until August, 2005.
Annotation: Promised to correct. |
* DATES OF INSPECTION
12/15/2005(Thu), 12/19/2005(Mon), 12/20/2005(Tue), 12/21/2005(Wed),
12/22/2005(Thu), 01/03/2006(Tue), 01/04/2006(Wed), 01/05/2006(Thu),
01/06/2006(Fri), 01/10/2006(Tue), 01/11/2006(Wed), 01/13/2006(Fri),
01/17/2006(Tue), 01/18/2006(Wed), 01/25/2006(Wed), 01/26/2006(Thu),
01/27/2006(Fri), 01/30/2006(Mon), 01/31/2006(Tue), 02/01/2006(Wed),
02/09/2006(Thu)
|
FDA EMPLOYEE'S NAME, TITLE, AND SIGNATURE:
[Handwritten Signature]
Alison A. Stone [hand amended to Alison
A. Nicoli], Investigator
[Handwritten Signature]
Ralph W. Jerndal, Investigator
|
SEE
REVERSE
OF THIS
PAGE |
|
This is a modified document |
DATE
ISSUED 02/09/2006 |
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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