FDA 483 - CASAD Company Inc - August 18, 2021

An FDA inspection of CASAD Company Inc, a hand sanitizer labeler in Coldwater, OH, revealed significant deficiencies across multiple quality systems. The firm failed to implement adequate quality control for incoming materials, lacked essential written procedures for deviations, investigations, and change control, and provided insufficient employee training. These observations indicate a systemic failure to adhere to cGMP requirements for drug product handling.