FDA WARNING_LETTER - LCC Ltd. - August 03, 2023

This FDA Warning Letter, dated August 3, 2023, addresses LCC Ltd., FEI 3007255059, a South Korean manufacturer of OTC drug products. The letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR, parts 210 and 211) based on a review of records submitted in response to a March 3, 2023 request under section 704(a)(4) of the FD&C Act.

The identified violations include: 1. **Failure to conduct identity testing for drug product components (21 CFR 211.84(d)(1)):** LCC Ltd. did not adequately test each shipment of incoming components, such as glycerin and propylene glycol, for high-risk contaminants like diethylene glycol (DEG) or ethylene glycol (EG) using USP identification tests. This failure means the acceptability of these components for drug manufacturing was not assured, posing a risk of lethal poisoning incidents. 2. **Failure to establish an adequate quality control unit (21 CFR 211.22(a)):** The firm's quality unit (QU) did not effectively exercise its responsibilities, specifically failing to adequately approve or reject components in the Materials System. The FDA expressed concern that the QU might also lack appropriate oversight in other CGMP operations like Production, Facilities & Equipment, Laboratory