FDA 483 - Safecor Health, LLC - October 27, 2015

Safecor Health, LLC in Woburn, MA, a drug manufacturer and repackager, received a Form 483 with 13 observations highlighting significant deficiencies across its quality system. Key issues include a lack of quality unit oversight in critical operations, inadequate investigation of discrepancies and complaints, insufficient production and process controls, and failures in equipment maintenance, cleaning validation, and personnel training. These findings indicate a systemic breakdown in ensuring drug product quality, identity, strength, and purity.