Woorilife & Health – FDA Warning Letter, Dec 27, 2023

The FDA issued a Warning Letter to Woorilife & Health, an OTC drug product manufacturer in South Korea, following a review of records submitted under section 704(a)(4) of the FD&C Act. The letter identifies significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under section 501(a)(2)(B) of the FD&C Act. Key violations include the firm's failure to conduct identity testing for each component of a drug product, specifically high-risk components like glycerin, propylene glycol, and sorbitol solution, to verify the absence of diethylene glycol (DEG) or ethylene glycol (EG) contamination, as required by 21 CFR 211.84(d)(1). Additionally, the firm failed to establish an adequate quality control unit with the necessary responsibility and authority to approve or reject components and oversee drug manufacturing operations, a violation of 21 CFR 211.22(a). The FDA recommends engaging a qualified CGMP consultant to evaluate operations and perform a comprehensive six-system audit. The firm was placed on Import Alert 66-40, and failure to correct violations may result in the FDA withholding approval of new applications or Export Certificates. A written response detailing corrective actions is required within 30 working days.