FDA WARNING_LETTER - Atlanta Supersource, Inc. - July 19, 2024

On January 8, 2025, the FDA issued a Warning Letter to Atlanta Supersource, Inc. following an inspection from July 15-19, 2024, at their Kennesaw, GA facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). Additionally, "INSTANT HAND SANITIZER Rinse-Free Gel" and "INSTANT HAND SANITIZER Rinse-Free Foam" were deemed misbranded under 21 U.S.C. 352(a).

Key violations include: 1. **Equipment Cleaning and Maintenance (21 CFR 211.67(a)):** The firm used the same equipment for manufacturing topical OTC hand sanitizers and toxic industrial chemical products, posing a cross-contamination risk. 2. **Finished Product Testing (21 CFR 211.165(a)):** The firm failed to adequately test drug products for identity and strength of the active ingredient, benzalkonium chloride (BZK), prior to release. 3. **Component Testing (21 CFR 211.84(d)(1) and 211.84(d)(2)):** The firm failed to conduct identity tests on each shipment of components (e.