# FDA WARNING_LETTER - Precision Analitica Integral S.A. de C.V. - February 05, 2021

Source: https://www.keypedia.com/records/warning_letter/precision-analitica-integral-sa-de-cv/c0ac5cd3-873d-42b6-947a-8ef6315f527f

> FDA WARNING_LETTER for Precision Analitica Integral S.A. de C.V. on February 05, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Precision Analitica Integral S.A. de C.V.
- Inspection Date: 2021-02-05
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Warning Letter, dated February 5, 2021, targets Precision Analitica Integral, a Mexican human drug manufacturer, concerning its CleanCare nogerm ADVANCED HAND SANITIZER. FDA testing of a product batch detained at the U.S. border revealed severe adulteration: the product, labeled for 75% ethyl alcohol, contained only 40% ethyl alcohol and 28% methanol, a toxic substance. This substitution constitutes adulteration under FD&C Act sections 501(d)(2) and 501(a)(2)(B), demonstrating a critical failure in Current Good Manufacturing Practice (CGMP) quality assurance. The hand sanitizer is also an unapproved new drug, violating section 505(a) of the FD&C Act, as it lacks FDA approval and does not conform to OTC monographs or temporary COVID-19 policies. It is misbranded under sections 502(j), (a), (e), (x), and (ee) for being dangerous due to methanol, having false labeling, failing to declare methanol, lacking a domestic contact for adverse events, and non-compliance with section 505G marketing requirements. The FDA demands a detailed investigation into testing failures, lists of raw materials/suppliers, batch reconciliations, complete batch records, and supplier qualification program details. Engaging a CGMP consultant is strongly recommended. All firm products are on Import Alert 66-78. A response detailing corrective actions is required within 15 working days.

## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)
- [Ernesto Casillas](https://www.keypedia.com/people/ernesto-casillas/9c70ca9c-4b16-4b49-b645-35cbb92ad887)
- [Benjamin L. England](https://www.keypedia.com/people/benjamin-l-england/ae9a60ca-9f13-4f56-b0ed-25c4ff2c90ff)
- [Samuel Casillas](https://www.keypedia.com/people/samuel-casillas/cb78d373-0fed-4f5b-bccf-190088a7b5b6)

Company: https://www.keypedia.com/companies/precision-analitica-integral-sa-de-cv/24b21f19-5244-4da1-b3e2-787b56bdfad4

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