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Glicerinas Industriales, S.A. de C.V., a Mexican manufacturer of drug components including glycerin, refused FDA's pre-announced inspection of its facility in February and March 2022, resulting in a determination that its drugs were adulterated under section 501(j) of the FD&C Act. The company's refusal to permit inspection was particularly significant given the known risks of glycerin contamination with diethylene glycol (DEG), which has caused lethal poisoning incidents worldwide. FDA placed the firm on Import Alert 66-79 on June 9, 2022, and stated it would withhold approval of any new drug applications or supplements listing the company as a manufacturer until the facility could be inspected and CGMP compliance confirmed.