Guangdong Renhe Guozhuang Biotechnology Co., Ltd.

Warning LetterOpen

Mr. Zhou Yigang Production Manager Guangdong Renhe Guozhuang Biotechnology Co., Ltd. No. 5, Tongfu Road, Xicheng Industrial Area Renhe Town Baiyun Qu Guangzhou Shi Guangdong Sheng , 510080FEI 3030384816Issued Dec 16, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3030384816.

Violations4

Issue DateDec 16, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Guangdong Renhe Guozhuang Biotechnology Co., Ltd.
Location: Mr. Zhou Yigang Production Manager Guangdong Renhe Guozhuang Biotechnology Co., Ltd. No. 5, Tongfu Road, Xicheng Industrial Area Renhe Town Baiyun Qu Guangzhou Shi Guangdong Sheng , 510080
FEI Number: 3030384816
Country: China
Issue Date: December 16, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

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.

Guangdong Renhe Guozhuang Biotechnology Co., Ltd. FDA Warning Letter, December 16, 2025