# FDA WARNING_LETTER - Quimica Magna de Mexico, S.A. de C.V. - October 15, 2020

Source: https://www.globalkeysolutions.net/records/warning_letter/quimica-magna-de-mexico-sa-de-cv/8a2b3f65-3dc7-4d6f-9747-7c6257136386

> FDA WARNING_LETTER for Quimica Magna de Mexico, S.A. de C.V. on October 15, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Quimica Magna de Mexico, S.A. de C.V.
- Inspection Date: 2020-10-15
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On October 15, 2020, the FDA issued a Warning Letter to Quimica Magna de Mexico, S.A. de C.V., a registered human drug manufacturer. The letter details violations concerning Datsen Hand Sanitizer and Alcohol Antiseptic 62% Topical Solution Hand Sanitizer products.

FDA testing of detained products revealed significant subpotency: Datsen Hand Sanitizer, labeled at 75% v/v ethanol, contained only 15% v/v, and Alcohol Antiseptic 62% Topical Solution Hand Sanitizer, labeled at 62% v/v ethanol, contained only 50% v/v. These levels are below the CDC-recommended minimum of 60% ethanol for hand sanitizers.

These products are deemed adulterated under section 501(c) of the FD&C Act due to their strength, purity, or quality falling below represented levels, and under section 501(a)(2)(B) for demonstrating a failure in quality assurance and non-compliance with Current Good Manufacturing Practice (CGMP) requirements.

Furthermore, the products are unapproved new drugs, violating section 505(a) of the FD&C Act, as they are not generally recognized as safe and effective (GRASE) and lack FDA approval. They are also misbranded under sections 502(a) and (ee)

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)
- [Mohsen Aminipour](https://www.globalkeysolutions.net/people/mohsen-aminipour/9d6d88d2-bedf-4ac3-9fba-9aebc0476e2d)
- [Maria del Socorro Muñiz Villarreal](https://www.globalkeysolutions.net/people/maria-del-socorro-muniz-villarreal/b797dfc8-9b70-43ce-8033-bae16cdb878c)

Company: https://www.globalkeysolutions.net/companies/quimica-magna-de-mexico-sa-de-cv/5a45b177-b01d-4047-8809-966b56537e8e

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