FDA 483 - Auto-Chlor System LLC - June 18, 2024

Auto-Chlor System LLC, a manufacturer and own label distributor of hand sanitizers and antibacterial hand soaps in Mapeville, GA, was cited for numerous significant cGMP violations during an FDA inspection. The firm failed to validate critical manufacturing processes, including its water system and equipment cleaning, and did not perform essential testing for identity, strength, and microbial contamination of drug products prior to release. Recurring issues also included inadequate quality control unit oversight, lack of essential SOPs, and deficiencies in laboratory controls, stability programs, and employee training.