FDA 483 - Safecor Health, LLC - September 01, 2023

Safecor Health, LLC, a drug repackager and relabeler in Columbus, OH, was cited for significant deficiencies in its quality control systems. Observations included inadequate stability programs, failure to verify component identity, unauthorized procedural changes, insufficient production and process controls, and poor investigation practices for discrepancies and out-of-specification results. These issues indicate a lack of robust quality oversight and control over critical drug product manufacturing and repackaging operations.