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Guangdong Renhe Guozhuang Biotechnology Co., Ltd., a manufacturer of over-the-counter drug products, failed to conduct appropriate laboratory testing and determination of satisfactory conformance to final specifications for each batch prior to release, including testing for identity, strength of active ingredients, and freedom from objectionable microorganisms, in violation of 21 CFR 211.165(a) and (b). These significant Current Good Manufacturing Practice (CGMP) violations rendered the company's drug products adulterated under the Federal Food, Drug, and Cosmetic Act. The FDA issued this warning following a records review conducted in response to a section 704(a)(4) inspection request issued on April 28, 2025.