Guidant Corporation, 483 Inspectional Observations, St Paul, Minnesota, dated 12/15/2005 - 02/09/2006
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.
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*
NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED
TO: Dale W. DeVries, Vice President of Clinicals and Regulatory Affairs
4100 Hamline Avenue NorthCITY,
STATE AND ZIP CODE
St. Paul, MN 55112
TYPE OF ESTABLISHMENT INSPECTED
Medical Device Manufacturer
DURING AN INSPECTION OF YOUR FIRM WEOBSERVED:
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.
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)
Alison A. Stone [hand amended to Alison A. Nicoli], Investigator
Ralph W. Jerndal, Investigator
FORM FDA 483 (7/00) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS
The observations of objectional conditions and practices listed on the front of this form are reported:
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.”