FDA WARNING_LETTER - Zermat International S.A. de C.V. - October 14, 2022

On April 6, 2023, the FDA issued a Warning Letter to Zermat Internacional S.A. de C.V. following an inspection from October 10-14, 2022, at their Tlalnepantla, Mexico facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to investigate OOS results (21 CFR 211.192):** The firm released OTC drug product batches with out-of-specification (OOS) viscosity and specific gravity results without adequate investigation. Their response acknowledging no OOS procedure and incorrect specifications was deemed inadequate, lacking retrospective review, a new OOS procedure with an implementation date, and scientific rationale for modified specifications. 2. **Inadequate stability testing program (21 CFR 211.166(a)):** The firm lacked sufficient stability data to support drug product shelf-life, with organoleptic assessments only at four weeks and no evidence of long-term stability or monitored storage conditions. Their proposed actions were insufficient without protocols, new testing results, and interim actions. 3. **Failure to validate manufacturing processes (21 CFR 211.100(a)):** The manufacturing processes for OTC drug products were