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Article: FDA inspection results in 8-point 483 for Stryker.(Medical Devices)
- Article from:
- Validation Times
- Article date:
- January 1, 2009
- Author:
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Cited for its failure to submit correction and removal reports when recalling out-of-specification (OOS) orthopedic implants following a June 1 July 12, 2007, inspection, Stryker Orthopaedics was reported for several GMP non-conformities.
FDA investigator Li Li observed that Stryker conducted three market withdrawals during 2006 and 2007 that were not reported to FDA.
On March 9, 2006, the Mahwah, NJ, company withdrew units of Trident PSL Acetabular Shells "due to a discovery of a machine operator's failures to inspect product dimensional features prior to release and OOS features from parts machined by the same individual during a QA investigation." In ...