Natuzen Co., Ltd. – FDA Warning Letter, May 14, 2024

The FDA issued a Warning Letter to Natuzen Co., Ltd. (FEI 3006731547) in South Korea, an OTC drug product manufacturer, after reviewing records submitted under section 704(a)(4) of the FD&C Act. The review identified significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under section 501(a)(2)(B) of the FD&C Act and 21 CFR parts 210 and 211. Key deficiencies include the firm's failure to conduct identity testing for drug product components, specifically not testing ethanol for methanol, which poses serious safety risks. Additionally, the firm failed to establish and follow adequate written procedures for cleaning and maintenance of non-dedicated manufacturing equipment, raising concerns about potential cross-contamination. Most critically, Natuzen Co., Ltd. failed to establish an adequate quality control unit with the authority to approve or reject materials and products, explicitly stating they "do not have a quality unit." The FDA recommends engaging a qualified CGMP consultant to perform a comprehensive six-system audit and evaluate corrective actions before resuming manufacturing for the U.S. market. The firm was placed on Import Alert 66-40, and failure to correct violations may lead to continued refusal of admission of their articles into the U.S. and withholding of new drug application approvals. A written response detailing corrective actions is required within 15 working days.