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Article: French firm not aware of MDR responsibilities; waits seven months to file report after device failures. (Medical Devices).
- Article from:
- Inspection Monitor
- Article date:
- June 1, 2003
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Saint Gobain Ceramiques Advancees Desmarquest, Cedex, France, Milwaukee District
France's Saint Gobain Ceramiques Advancees Desmarquest received a two-item 483 following a baseline Quality Systems Inspection Technique (QSIT) audit, which turned up device failures and the recall of eight batches of ceramic femoral heads for hip implants distributed in the U.S. and other countries.
Richard Tucker of FDA's Milwaukee District conducted this initial inspection the Cedex-based firm, following a Center for Devices request from the Division of Enforcement and Office of Compliance.
Tucker noted in the EIR that Saint Gobain Ceramiques retained a private ...