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C&T Dream Co., Ltd., a South Korean drug manufacturer, failed to comply with Current Good Manufacturing Practice (CGMP) regulations for its over-the-counter topical product, Dry Skin Healing Ointment, during an FDA inspection conducted in November 2023. The company violated 21 CFR 211.84(d)(1) by failing to conduct identity testing on incoming components, particularly those at high risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination, such as glycerin used in the drug product. The firm did not perform required USP limit tests to ensure components met safety standards for DEG or EG levels, rendering the drug product adulterated under the Federal Food, Drug, and Cosmetic Act. The FDA issued this warning letter after the company failed to respond with corrective actions following the inspection findings.