FDA 483 - Safecor Health, LLC - March 16, 2023

Safecor Health, LLC, a human drug product manufacturer and repackager in Woburn, MA, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to thoroughly investigate out-of-specification results and customer complaints, maintain adequate line clearance, and properly clean and maintain equipment. Additionally, issues were noted with documentation practices and the validation of purified water USP supplier analyses.