FDA 483 - CASAD Company Inc - October 08, 2025

An FDA inspection of CASAD Company Inc, a drug product relabeler in Coldwater, OH, revealed significant deficiencies in quality control and record-keeping. The firm lacked written procedures for managing deviations, corrective actions, and investigations, and failed to document deviations or maintain quality agreements with contract manufacturers. Additionally, the company did not prepare or maintain batch production and control records for any of its relabeled drug products, a critical lapse given the release of numerous batches without such documentation.