Mr. Adelfo Enriquez Rios
President and CEO
Zermat International S.A. de C.V.
Calle Lazaro Cardenas No. 47
Unidad Habitacional San Jeronimo, Tepetlacalco
Tlalnepantla De Baz
54090 Tlalnepantla , Méx.
MexicoFEI 3003659249Issued Apr 6, 2023Center for Drug Evaluation and Research | CDER
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3003659249.
Violations5
Issue DateApr 6, 2023
Product TypeDrugs
StatusOpen
Letter Details
Firm
Zermat International S.A. de C.V.
Location
Mr. Adelfo Enriquez Rios
President and CEO
Zermat International S.A. de C.V.
Calle Lazaro Cardenas No. 47
Unidad Habitacional San Jeronimo, Tepetlacalco
Tlalnepantla De Baz
54090 Tlalnepantla , Méx.
Mexico
FEI Number
3003659249
Country
Mexico
Issue Date
April 06, 2023
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
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.
Zermat International S.A. de C.V. FDA Warning Letter, April 6, 2023
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