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Article: French firm not aware of medical device reporting responsibilities.(Medical devices)
- Article from:
- Validation Times
- Article date:
- July 1, 2003
- Author:
CopyrightCOPYRIGHT 2003 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Device failures and the recall of eight batches of ceramic femoral heads for hip implants distributed in the U.S. and other countries prompted a baseline Quality Systems Inspection Technique (QSIT) audit, at France's Saint Gobain Ceramiques Advancees Desmarquest facility. The firm received a two-item 483 for not reporting the device failures as required.
Richard Tucker of FDA's Milwaukee District conducted this initial inspection of the Cedex-based firm, following a Center for Devices request from the Division of Enforcement and Office of Compliance.
While Saint Gobain retained a private consulting firm to bring quality systems and associated procedure ...