FDA 483 - COSMAX, INC. - October 18, 2024

During an inspection, COSMAX, INC., a pharmaceutical manufacturer in Hwaseong-si, Gyeonggi-do, Korea, was cited for significant deficiencies in its investigation procedures. The firm's written records for out-of-specification chemistry results and supplier nonconformances consistently failed to include complete root cause evaluations and adequate follow-up actions to prevent reoccurrence. This indicates a systemic issue with their quality control and corrective action processes.