# FDA WARNING_LETTER - Maquiladora Miniara SA de CV - December 15, 2021

Source: https://www.keypedia.com/records/warning_letter/maquiladora-miniara-sa-de-cv/6ab7596a-7b31-41c5-9cbf-0143b1079569

> FDA WARNING_LETTER for Maquiladora Miniara SA de CV on December 15, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Maquiladora Miniara SA de CV
- Inspection Date: 2021-12-15
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On December 15, 2021, the FDA issued a Warning Letter to Maquiladora Miniara S.A. de C.V., a registered human drug manufacturer, following the detention and refusal of Shine and clean Hand Sanitizer Gel imports into the U.S. FDA testing revealed the product, labeled to contain 70% ethyl alcohol, actually contained significantly lower ethanol concentrations (e.g., 2.2%, 1.0%, 49%, 1%) and high levels of undeclared methanol (e.g., 43%, 77%, 3.3%, 75%) and isopropanol.

This substitution of active ingredients with dangerous chemicals like methanol renders the product adulterated under section 501(d)(2) of the FD&C Act. The presence of methanol, a toxic substance, also indicates a failure of the firm's quality assurance system to comply with Current Good Manufacturing Practice (CGMP) requirements, violating section 501(a)(2)(B).

Furthermore, Shine & clean Hand Sanitizer Gel is an unapproved new drug under section 505(a) and misbranded under sections 502(j), (a), (e), (x), and (ee) of the FD&C Act. It is dangerous to health due to methanol, its labeling is false/misleading regarding ethanol content and undeclared methanol

## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)
- [David Lennarz](https://www.keypedia.com/people/david-lennarz/7524fe46-01da-49a0-b6c1-45210bf91809)

Company: https://www.keypedia.com/companies/maquiladora-miniara-sa-de-cv/b58182c8-094d-4eaa-bf98-333f61046942

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