Precision Analitica Integral S.A. de C.V.

Warning LetterOpen

Mr. Alan Williams CEO Precision Analitica Integral S.A. de C.V. Calle De Minas 501 Bodega 21 Col. Arvide Alvaro Obregon , CDMX MexicoFEI 3016855928Issued Feb 5, 2021Center for Drug Evaluation and Research | CDER

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3016855928.

Violations3

Issue DateFeb 5, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Precision Analitica Integral S.A. de C.V.
Location: Mr. Alan Williams CEO Precision Analitica Integral S.A. de C.V. Calle De Minas 501 Bodega 21 Col. Arvide Alvaro Obregon , CDMX Mexico
FEI Number: 3016855928
Country: Mexico
Issue Date: February 05, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Precision Analitica Integral S.A. de C.V., a Mexican drug manufacturer, was cited for producing CleanCare nogerm ADVANCED HAND SANITIZER, an unapproved hand sanitizer product that was adulterated due to substance substitution and failed quality assurance controls in violation of Current Good Manufacturing Practice requirements. FDA laboratory testing of a batch detained at the U.S. border confirmed the product was adulterated under sections 501(d)(2) and 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act, and the product was also found to be misbranded and introduced into interstate commerce without approval under section 505(a).

Precision Analitica Integral S.A. de C.V. FDA Warning Letter, February 5, 2021