FDA WARNING_LETTER - reBom Co., Ltd. - July 09, 2024

This FDA Warning Letter, dated June 26, 2024, was issued to reBom Co., Ltd., 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 FDA identified significant Current Good Manufacturing Practice (CGMP) violations, rendering the firm's drug products adulterated under section 501(a)(2)(B) of the FD&C Act. Key deficiencies include the firm's failure to establish and follow an adequate written stability testing program (21 CFR 211.166(a)), lacking sufficient data to support product expiration dates. Additionally, the firm failed to adequately test incoming components for identity, purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)), specifically noting insufficient testing for (b)(4) and for diethylene glycol (DEG) and ethylene glycol (EG) in glycerin, posing lethal poisoning risks. The firm also failed to demonstrate adequate finished drug product testing, including active ingredient assay and microbiological testing. The FDA recommends engaging a qualified CGMP consultant (21 CFR 211.34) to conduct a comprehensive six-system audit and evaluate corrective actions. Failure to promptly address these violations may result in FDA withholding approval of new applications, re-inspection, and refusal of admission of products into the U.S. The firm must respond within 15 working days detailing corrective actions and prevention plans.