Gascó Industrial Corporation – FDA Warning Letter, Oct 18, 2022

On February 17, 2023, the FDA issued a Warning Letter to Gascó Industrial Corporation following an inspection from October 11-18, 2022. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The company's November 15, 2022, response to the FDA 483 was deemed inadequate.

Key violations include: 1. **Inadequate Separate Areas (21 CFR 211.42(c)):** The firm manufactures OTC drug products using the same equipment as non-pharmaceutical materials (industrial detergents/disinfectants), 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 previously produced drugs on shared equipment, including potential recalls. 2. **Inadequate Production and Process Controls (21 CFR 211.100(a)):** * **Inadequate Cleaning Controls:** Cleaning procedures are insufficient, and drug product areas/filling equipment were soiled. * **Inadequate Water System Design and Controls:** Lack of validation studies for the water system, failing to demonstrate consistent production of pharmaceutical-grade water. * **Inadequate Process Controls:** Absence of