Mr. Guo Guorong
Chairman & General Manager
Guangxi Yulin Pharmaceutical Group Co. Ltd.
No. 1 Chengzhan Rd.
Yulin Shi
Guangxi Zhuangzuzizhiqu , 537001
ChinaFEI 1000589993Issued Sep 30, 2025Center 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 1000589993.
Violations5
Issue DateSep 30, 2025
Product TypeDrugs
StatusOpen
Letter Details
Firm
Guangxi Yulin Pharmaceutical Group Co. Ltd.
Location
Mr. Guo Guorong
Chairman & General Manager
Guangxi Yulin Pharmaceutical Group Co. Ltd.
No. 1 Chengzhan Rd.
Yulin Shi
Guangxi Zhuangzuzizhiqu , 537001
China
FEI Number
1000589993
Country
China
Issue Date
September 30, 2025
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Guangxi Yulin Pharmaceutical Group Co. Ltd. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of finished pharmaceutical drugs following an FDA inspection in March 2025. The company failed to perform appropriate laboratory testing to determine identity and strength of active ingredients prior to drug product release and distribution, a repeat violation from a 2016 inspection, thereby producing adulterated drug products that did not conform to final specifications. The firm's response to FDA's initial inspection findings was deemed inadequate due to lack of supportive documentation and insufficient evidence of corrective actions taken to achieve compliance.
Guangxi Yulin Pharmaceutical Group Co. Ltd. FDA Warning Letter, September 30, 2025
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