Limpo Quimicos, SA de CV

Warning LetterOpen

Mr. Santiago Alvarado General Director Limpo Quimicos, SA de CV Privada Jose Silvestre Aramberri No. 149, Col. Solidaridad 66058 General Escobedo , N.L. MexicoFEI 3016628153Issued Sep 30, 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 3016628153.

Violations3

Issue DateSep 30, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Limpo Quimicos, SA de CV
Location: Mr. Santiago Alvarado General Director Limpo Quimicos, SA de CV Privada Jose Silvestre Aramberri No. 149, Col. Solidaridad 66058 General Escobedo , N.L. Mexico
FEI Number: 3016628153
Country: Mexico
Issue Date: September 30, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

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.

Limpo Quimicos, SA de CV FDA Warning Letter, September 30, 2021