C&G Laboratorios SA de CV Warning Letter Details

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.