Limpo Quimicos, SA de CV Warning Letter Details

Summary

Limpo Quimicos, SA de CV, a Mexican drug manufacturer, was cited for producing adulterated and unapproved hand sanitizer products (Andy's Best Advanced Hand Sanitizer and NeoNatural gel Hand Sanitizer) that were detained at the U.S. border. FDA laboratory testing found that Andy's Best products contained substituted substances in violation of the FD&C Act, while NeoNatural gel was subpotent with strength, purity, or quality below labeled claims. The company's quality assurance system failed to comply with Current Good Manufacturing Practice (CGMP) requirements, as evidenced by these substitution and subpotency issues. Additionally, both products were unapproved new drugs introduced into U.S. commerce without proper FDA authorization.