Validation problems and FDA reporting lapses result in 8-point 483 for Stryker.(MEDICAL DEVICES)

Inspection Monitor | January 1, 2009 | Copyright

Stryker Orthopaedics, Mahwah, NJ Parsippany District

Stryker was cited for failing to submit reports of corrections and removals to FDA when recalling out-of-specification orthopedic implants, among other GMP non-conformities, following an inspection June 1-July 12, 2007.

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 company withdrew units of Trident PSL Acetabular Shells "due to a discovery of a machine operator's failures to inspect product ...

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