Tropicosmeticos SA de CV Warning Letter Details

Summary

Tropicosmeticos SA de CV was warned for manufacturing Britz Hand Sanitizer, an unapproved new drug that was adulterated and misbranded in violation of federal law. FDA laboratory testing of a batch detained at the U.S. border revealed that the product's active ingredient (ethyl alcohol) was substituted wholly or in part, demonstrating failures in the company's quality assurance and Current Good Manufacturing Practice (CGMP) compliance. The product was labeled to contain 70% ethanol but did not meet this specification, and it lacked required FDA approval for introduction into interstate commerce.