Mr. Honghui Cheng
Legal Representative and Chairman of the Board
Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd.
249 Poyang Road
Huangqi, Dali Town
Nanhai Qu
Foshan Shi
Guangdong Sheng , 528248FEI 3006010954Issued Aug 1, 2024Center for Drug Evaluation and Research (CDER)
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 3006010954.
Mr. Honghui Cheng
Legal Representative and Chairman of the Board
Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd.
249 Poyang Road
Huangqi, Dali Town
Nanhai Qu
Foshan Shi
Guangdong Sheng , 528248
FEI Number
3006010954
Country
China
Issue Date
August 01, 2024
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of finished pharmaceutical drugs during an FDA inspection in December 2023. The company failed to establish appropriate laboratory controls, including scientifically sound specifications and analytical testing procedures for critical quality attributes, and failed to develop proper release specifications and test procedures for over-the-counter drug products. Notably, the company's certificate of analysis for at least one OTC product listed only a single active ingredient despite the label claiming two active ingredients, indicating deficiencies in quality control and product consistency. The violations rendered the firm's drug products adulterated under the Federal Food, Drug, and Cosmetic Act.
Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. FDA Warning Letter, August 1, 2024
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