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

Source: https://www.globalkeysolutions.net/records/warning_letter/zermat-international-sa-de-cv/8ec5d949-6876-46af-a017-91b0f5fce363

> FDA WARNING_LETTER for Zermat International S.A. de C.V. on October 14, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Zermat International S.A. de C.V.
- Inspection Date: 2022-10-14
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

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- [Director](https://www.globalkeysolutions.net/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

Company: https://www.globalkeysolutions.net/companies/zermat-international-sa-de-cv/5e307550-f1eb-48a1-85f3-91aa80a651bc

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c