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# CGMP Violations at Zermat International
- URL: https://www.fdaweb.com/cgmp-violations-at-zermat-international/
- Published: 2023-04-19T12:00:00.000Z
- Updated: 2026-09-14T18:26:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154246

A 10/10-10/14/22 FDA inspection at the Zermat International drug manufacturing facility in Tlalnepantla, Mexico, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/6 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zermat-international-sa-de-cv-647232-04062023?ref=fdaweb.com) says specific violations were:

- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed;
- failing to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use the results of stability testing to determine appropriate storage conditions and expiration dates;
- failing to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess; and
- failure of the quality control unit to exercise its responsibility to ensure that manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter says the firm’s quality systems are inadequate and says similar violations were noted in a previous inspection that covered another type of over-the-counter drug product.

“At that time, your firm discontinued the distribution and manufacturing of that drug product,” FDA says. “However, the current inspection found repeated violations related to process validation and stability. These repeated failures demonstrate that management oversight and control over the manufacture of drug products are inadequate.”

Zermat was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.