AAA Cosmetica, SA de CV Warning Letter Details

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.