FDA WARNING_LETTER - Vintage Chemical Inc. - November 20, 2023

On March 27, 2024, the FDA issued a Warning Letter to Vintage Chemical, Inc. following an inspection from November 13-20, 2023, at their Fort Wayne, Indiana facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under the FD&C Act.

Key violations include: 1. **Failure to prevent contamination/mix-ups (21 CFR 211.42(c)):** The firm manufactures OTC antibacterial hand soap and hand sanitizer using the same equipment as industrial detergents and degreasing products, posing a cross-contamination risk. The FDA requires confirmation of discontinuing shared equipment or a plan for dedicated manufacturing areas, plus a risk assessment for all previously produced drugs on shared equipment, including potential recalls. 2. **Failure to perform adequate finished product testing (21 CFR 211.165(a) and 211.165(b)):** The firm failed to conduct potency and microbiological testing on hand sanitizer and antibacterial hand soap prior to release. The FDA requires an action plan and timelines for full chemical and microbiological testing of retain samples for all in-expiry distributed batches, and a summary of results, with rapid corrective actions for substandard products. 3. **Failure to test components for identity and conformity (21 CFR 211.84