FDA 483 - Safecor Health, LLC - March 07, 2011

Safecor Health, LLC, a drug manufacturer and repackager in Woburn, MA, was cited for significant quality control deficiencies during an FDA inspection. Observations included inadequate investigations into product discrepancies and complaints, insufficient cleaning validation for non-dedicated equipment, and a lack of proper stability data to support drug product expiration dates. The firm also failed to ensure proper facility design to prevent contamination and maintain the building in a good state of repair.