Loading…
LCC Ltd., a South Korean manufacturer of over-the-counter drug products including mouthwash, received this warning for significant Current Good Manufacturing Practice (CGMP) violations that rendered their finished pharmaceuticals adulterated. The company failed to conduct required identity testing on incoming components at high risk of contamination, specifically failing to test glycerin, propylene glycol, and other ingredients for diethylene glycol (DEG) and ethylene glycol (EG) contamination using United States Pharmacopeia (USP) limit tests. This violation of 21 CFR 211.84(d)(1) meant the firm could not verify that component shipments met appropriate safety limits for these dangerous contaminants.