FDA 483 - Auto-Chlor System LLC - July 18, 2022

During an inspection conducted from July 5 to July 18, 2022, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Auto-Chlor System LLC, a drug manufacturer located in Hapeville, GA. The inspection revealed significant deficiencies in the company's adherence to current Good Manufacturing Practices (cGMP) for its hand sanitizer drug products. Key observations included a lack of process validation for manufacturing hand sanitizers and the cleaning of shared equipment. The company failed to conduct adequate laboratory testing, specifically not verifying the identity and strength of active ingredients like Benzalkonium Chloride, Benzethonium Chloride, and Ethanol prior to product release. Multiple instances showed non-adherence to internal standard operating procedures for testing hand sanitizer blends. Furthermore, the quality control unit exhibited several shortcomings, including the absence of crucial SOPs for change control, annual product reviews, returns, and complaints. The unit also failed to properly review and approve procedures or document production record evaluations. Repeat observations highlighted an inadequate stability testing program, lack of finished product microbial testing per batch, and a failure to thoroughly investigate product discrepancies, mislabeling, or out-of-specification results. The firm also relied on supplier certificates of analysis without performing identity testing on raw materials or validating supplier data. Incomplete distribution and master production records further contributed to the identified issues. Auto-Chlor System LLC is required to address these serious deviations to ensure the quality, safety, and efficacy of its drug products.