FDA WARNING_LETTER - C&G Laboratorios SA de CV - October 09, 2020

The FDA issued a Warning Letter to C&G Laboratorios S.A. de C.V. on April 26, 2021, following the detention and refusal of admission of their HAND SANITIZER DISINFECTANT GEL at the U.S. border. FDA testing revealed the product, labeled to contain 70% ethyl alcohol, actually contained only 1.1% ethanol and 65% methanol. This led to multiple violations: the product is adulterated under sections 501(d)(2) and 501(a)(2)(B) of the FD&C Act due to active ingredient substitution with toxic methanol and a failure of quality assurance/CGMP. It is also an unapproved new drug under section 505(a) as it lacks FDA approval and does not conform to the 1994 TFM or meet 505G requirements. Furthermore, the product is misbranded under sections 502(j), (a), (e), and (ee) of the FD&C Act because it is dangerous to health, its labeling is false or misleading (e.g., claiming "disinfectant" use, misrepresenting ethanol concentration), it fails to list methanol as an ingredient, and does not comply with 505G. The FDA strongly recommends engaging a qualified CGMP consultant. The firm must respond within 15 working days detailing corrective actions. All drugs from the firm are on Import Alert 66-78, meaning they may be detained until compliance is demonstrated, potentially requiring an FDA inspection.