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Within the warning letter, the FDA states, “your component identity testing did not include a limit test for diethylene glycol (DEG) and ethylene glycol (EG) on all lots of glycerin before use in the manufacture of your drug products.” 15 The FDA includes specific concerns surrounding DEG or EG contamination in 37 of the 111 inspection-based warning letters issued in FY24 and it recommends review of the guidance document, Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol , to help meet cGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination
