C&G Laboratorios SA de CV

Warning LetterOpen

Mr. Yoshua Rostenberg Legal Representative C&G Laboratorios SA de CV Pestalozzi No. 415, Navarte 03020 Benito Juarez , CDMX MexicoFEI 3008749537Issued Apr 26, 2021Center for Drug Evaluation and Research

View Letter

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 3008749537.

Violations3

Issue DateApr 26, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: C&G Laboratorios SA de CV
Location: Mr. Yoshua Rostenberg Legal Representative C&G Laboratorios SA de CV Pestalozzi No. 415, Navarte 03020 Benito Juarez , CDMX Mexico
FEI Number: 3008749537
Country: Mexico
Issue Date: April 26, 2021
Issuing Office: Center for Drug Evaluation and Research
Product Type: Drugs
Status: Open

Summary

C&G Laboratorios SA de CV manufactured a hand sanitizer product labeled to contain 70% ethanol that was found to be adulterated due to substitution of its active ingredient, violating Current Good Manufacturing Practice (CGMP) requirements and demonstrating failed quality assurance. The product was also an unapproved new drug and misbranded under multiple sections of the Federal Food, Drug, and Cosmetic Act. The batch was detained and refused admission at the U.S. border following FDA laboratory testing that confirmed the adulterations.

C&G Laboratorios SA de CV FDA Warning Letter, April 26, 2021