Zermat International S.A. de C.V. Warning Letter Details

Summary

Zermat International S.A. de C.V., a Mexican pharmaceutical manufacturer, violated Current Good Manufacturing Practice (CGMP) regulations for finished drug products when the FDA inspected its facility in October 2022. The company failed to adequately investigate out-of-specification (OOS) results for multiple over-the-counter drug product batches, releasing and distributing products with viscosity and specific gravity failures without proper investigation, and acknowledged it lacked procedures to handle OOS results. The company's November 2022 response to FDA's Form 483 observations was deemed inadequate due to insufficient detail and evidence of corrective actions to achieve CGMP compliance, resulting in the drug products being deemed adulterated.