FDA WARNING_LETTER - K. Boeun Pharmaceutical Co., Ltd. - August 11, 2023

The FDA issued a Warning Letter to K. Boeun Pharmaceutical Co., Ltd. (FEI 3016756938) on August 14, 2023, following a review of records submitted per a March 3, 2023, request under section 704(a)(4) of the FD&C Act. The facility, an OTC drug product manufacturer, was found to have significant Current Good Manufacturing Practice (CGMP) violations, rendering its drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to conduct identity testing for drug components (21 CFR 211.84(d)(1)):** The firm did not adequately test each shipment of high-risk components like glycerin and sorbitol solution for diethylene glycol (DEG) or ethylene glycol (EG) contamination using USP identification tests. This poses a significant safety risk. 2. **Inadequate Quality Control Unit (QCU) (21 CFR 211.22(a)):** The QCU failed to effectively oversee drug manufacturing operations, specifically in approving or rejecting components in the Materials System. Concerns were raised about potential lack of oversight in other CGMP areas like Production, Facilities & Equipment, Laboratory Controls, and Packaging & Labeling.

The FDA recommends engaging a qualified CG