FDA 483 - Safecor Health, LLC - October 28, 2025

Safecor Health, LLC, a manufacturer and repackager in Woburn, MA, was cited for significant deficiencies in its quality control unit during an FDA inspection from October 22-28, 2025. The firm failed to consistently follow its own written procedures for Corrective and Preventative Action (CAPA) management, Deviation management, and Out-of-Specification (OOS) investigations. These issues primarily concerned timely closure and proper documentation of extensions, indicating a systemic breakdown in maintaining control over critical quality processes.