FDA 483 - Upsher Smith Laboratories, Inc. - December 19, 2018

The FDA inspected Upsher Smith Laboratories, Inc. in Plymouth, MN, identifying significant deficiencies in quality control unit procedures, batch production records, equipment cleaning, and dietary supplement quality. The firm failed to follow written change control procedures, ensure component traceability for drug products, adequately define equipment hold times, and maintain proper records, leading to the release of sub-potent niacin dietary supplements.