Cosmelab Co Ltd – FDA Warning Letter, Jul 17, 2019

The FDA inspected Cosmelab Co., Ltd. in Seoul, South Korea, from July 15-17, 2019, identifying significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211). This renders their drug products adulterated under section 501(a)(2)(B) of the FD&C Act.

A primary violation was the firm's failure to establish an adequate quality control unit (QCU) with authority to approve or reject materials and products (21 CFR 211.22(a)). Specifically, they failed to ensure assay tests were performed and reviewed for OTC drug products prior to release. The firm also lacked QCU oversight of drug manufacturing and testing by contracted facilities. Furthermore, Cosmelab released OTC drug products to the U.S. market manufactured by a contract manufacturer on FDA's Import Alert 66-40, unaware of this status.

Cosmelab's August 6, 2019, response was deemed inadequate as it lacked a detailed interim plan for establishing a comprehensive QCU. The FDA requires a comprehensive independent assessment and remediation plan for the QCU, a retrospective evaluation of drug products on the U.S. market for quality/safety risks, a list of chemical specifications and test methods, and a detailed plan for ongoing assessments of components and a robust supplier qualification program