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Talk to a SpecialistTalk to a SpecialistK. Boeun Pharmaceutical Co., Ltd., a South Korean manufacturer of over-the-counter drug products, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated drug products. The company failed to conduct required identity testing on incoming components at high risk of contamination with diethylene glycol (DEG) or ethylene glycol (EG), specifically including glycerin and sorbitol solution used in drug manufacturing, as required by 21 CFR 211.84(d)(1). The FDA found that the manufacturer did not adequately test each shipment of high-risk components to verify they met relevant safety limits, nor did they demonstrate compliance with USP identity testing standards for these materials.