AAA Cosmetica, SA de CV

Warning LetterOpen

Mr. Albert Pla Andreu Chief Executive Officer AAA Cosmetica, SA de CV Recursos Hidraulicos No.1 Seccion A Col. La Loma Zona Industrial 54060 Tlalnepantla , Méx. MexicoFEI 3009065443Issued Feb 3, 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 3009065443.

Violations3

Issue DateFeb 3, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: AAA Cosmetica, SA de CV
Location: Mr. Albert Pla Andreu Chief Executive Officer AAA Cosmetica, SA de CV Recursos Hidraulicos No.1 Seccion A Col. La Loma Zona Industrial 54060 Tlalnepantla , Méx. Mexico
FEI Number: 3009065443
Country: Mexico
Issue Date: February 03, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

AAA Cosmetica, SA de CV was cited for manufacturing an unapproved hand sanitizer product labeled "bio aaa ADVANCE HAND SANITIZER" that violated multiple provisions of the Federal Food, Drug, and Cosmetic Act, including operating as an unapproved new drug and misbranding. FDA laboratory testing of product detained at the U.S. border found the hand sanitizer to be adulterated due to substance substitution, indicating failed quality assurance and non-compliance with Current Good Manufacturing Practice (CGMP) requirements. The product was refused admission into the United States, and the company was notified that introduction or delivery of such products into interstate commerce is prohibited.

AAA Cosmetica, SA de CV FDA Warning Letter, February 3, 2021