FDA WARNING_LETTER - Green Pharmaceutical Co. Ltd. - September 05, 2023

The FDA issued a Warning Letter to Green Pharmaceutical Co. Ltd. (FEI 3013338037) in South Korea on August 23, 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, registered as an OTC drug manufacturer, was found to have significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR, parts 210 and 211), rendering its drug products adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Failure to conduct identity testing for drug product components (21 CFR 211.84(d)(1))**: The firm did not adequately test each shipment of high-risk components, such as (b)(4), for identity, including a USP limit test for (b)(4) contamination, which has been linked to lethal poisoning incidents. 2. **Failure to establish an adequate quality control unit (21 CFR 211.22(a))**: The Quality Unit (QU) did not effectively oversee drug manufacturing operations, specifically failing to approve or reject components in the Materials System. Concerns were raised about the QU's oversight in other CGMP areas like Production