FDA WARNING_LETTER - C&T Dream Co., Ltd. - November 10, 2023

On April 11, 2024, the FDA issued a Warning Letter to C&T Dream Co., Ltd. following an inspection from November 6-10, 2023, at their Cheonan-si, Republic of Korea facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug product adulterated under 21 U.S.C. 351(a)(2)(B). The firm had not responded to the initial FDA 483.

Violations included: 1. Failure to conduct identity testing for each component of a drug product (21 CFR 211.84(d)(1)), specifically for high-risk components like glycerin, to ensure absence of diethylene glycol (DEG) or ethylene glycol (EG) contamination. 2. Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a)), indicating a lack of process validation to assure consistent drug product quality. 3. Failure to maintain buildings in a good state of repair (21 CFR 211.58), evidenced by water damage, mold-like substance, and active leaks in the R&D Center Building, which is used for manufacturing and storage.

These observations were repeat violations from a July 2017 inspection, indicating inadequate executive management oversight. The firm