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

On December 20, 2022, the FDA issued a Warning Letter to Auto-Chlor System LLC following an inspection from July 5-18, 2022, at their Hapeville, GA facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to establish and follow written procedures for equipment cleaning and maintenance (21 CFR 211.67(b))**: The firm used the same equipment for drug products and industrial cleaners, risking cross-contamination, and observed inadequate cleaning. 2. **Failure to test components for identity, purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2))**: The firm did not test incoming ethanol for methanol and relied on unqualified supplier Certificates of Analysis. Additionally, the firm used (b)(4) water as a component without testing for suitability or meeting USP purified water monograph standards. 3. **Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a))**: The firm lacked process validation and equipment qualification for hand sanitizer manufacturing. 4. **Quality control unit failure to ensure CGMP compliance (21 CFR 211.22)**: The Quality