FDA WARNING_LETTER - Glicerinas Industriales, S.A. de C.V. - May 20, 2022

The FDA issued a Warning Letter to Glicerinas Industriales, S.A. de C.V. (GLINSA) after the firm refused a pre-announced inspection of its drug manufacturing facility in Zapopan, Mexico, on February 24, 2022, and again after written notification on March 23, 2022. GLINSA is a supplier of drug components, such as glycerin, which carries a risk of diethylene glycol (DEG) contamination, known to cause lethal poisoning. The refusal to permit inspection renders the firm's drugs adulterated under section 501(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(j). Consequently, FDA placed GLINSA on Import Alert 66-79, may withhold approval of new drug applications listing the firm, and will subject future shipments to detention or refusal of admission into the U.S. GLINSA must respond in writing within 15 working days, providing additional information or requesting to schedule an FDA inspection to address these serious compliance issues.