# FDA WARNING_LETTER - Jose Miguel Gutierrez Salas - July 21, 2022

Source: https://www.keypedia.com/records/warning_letter/jose-miguel-gutierrez-salas/e2623198-3566-4bf4-8089-79fa3d489238

> FDA WARNING_LETTER for Jose Miguel Gutierrez Salas on July 21, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Jose Miguel Gutierrez Salas
- Inspection Date: 2022-07-21
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Jose Miguel Gutierrez Salas (FEI 3016833431) in Tepic, Mexico, on July 21, 2022, following the detention and refusal of MVP Sanitizing Services SPRAY HAND SANITIZER at the U.S. border. FDA testing revealed the product, labeled to contain ethanol, instead contained 0% ethanol and an average of 63% methanol, a toxic substance.

This constitutes several violations:
1.  **Adulteration:** The product is adulterated under 21 U.S.C. 351(d)(2) due to the substitution of ethanol with methanol, and under 21 U.S.C. 351(a)(2)(B) indicating a failure in Current Good Manufacturing Practice (CGMP) quality assurance.
2.  **Unapproved New Drug:** The hand sanitizer is an unapproved new drug under 21 U.S.C. 355(a) as it is not generally recognized as safe and effective (GRASE) and lacks FDA approval. It does not conform to any applicable Tentative Final Monograph (TFM) or temporary FDA policies, notably containing undeclared methanol and impermissible active ingredients (deionized water, glycerin, emollients).
3.  **Misbranding:** The product is misbranded under 21 U.

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

Company: https://www.keypedia.com/companies/jose-miguel-gutierrez-salas/aec96a43-8a33-4a76-813d-03011d49eedd

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