# China NMPA Drug Inspection - Hunan Wugan Pharmaceutical Co., Ltd. - Ginkgo leaf medicine

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/hunan-wugan-pharmaceutical-co-ltd/98526c85-51a7-4143-81fd-3d563e765f91/
Source feed: China

> China NMPA drug inspection for Hunan Wugan Pharmaceutical Co., Ltd. published July 31, 2015. Drug: Ginkgo leaf medicine. The State Food and Drug Administration (SFDA) of China conducted special supervision and sampling inspections of Ginkgo 

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 47 of 2015 from the State Food and Drug Administration on the Second Batch of Results of Special Supervision and Sampling Inspection of Ginkgo Leaf Drugs
- Company Name: Hunan Wugan Pharmaceutical Co., Ltd.
- Publication Date: 2015-07-31
- Drug Name: Ginkgo leaf medicine
- Inspection Finding: Inconsistencies were again found between self-inspection results and supervisory spot check results (4 batches); 6 batches of products passed self-inspection but failed supervisory spot check due to oversights and incorrect information reported by the companies.
- Action Taken: All commercially available products within their expiration dates have been recalled; recall measures have been taken for all substandard drugs, including these six batches.
- Summary: The State Food and Drug Administration (SFDA) of China conducted special supervision and sampling inspections of Ginkgo biloba drugs between June 16 and July 20, 2015, releasing its second batch of results on July 31, 2015. Out of 194 batches sampled, 118 were found to be substandard, involving 31 pharmaceutical manufacturers.

Key violations included significant inconsistencies between companies' self-inspection results and the SFDA's random inspections, suggesting unreliable internal testing or sample substitution. For example, Hubei Wushi Pharmaceutical Co., Ltd. failed the random inspection despite its own qualified report. More severe issues involved companies like Heilongjiang Tianhong Pharmaceutical Co., Ltd., Jilin Kuahai Biochemical Pharmaceutical Manufacturing Co., Ltd., and Ningbo Lihua Pharmaceutical Co., Ltd., which were found to have tampered with retained samples to falsify evidence. Hunan Huana Pharmaceutical Co., Ltd. was cited for negligence and incorrect information reporting. Furthermore, nine companies failed to complete product recalls within the specified timeframe.

Under the SFDA's regulatory framework, implicated companies were required to immediately recall all substandard products. Provincial food and drug administrations were directed to conduct thorough investigations into these violations, impose severe penalties, and hold quality management personnel accountable. Investigation results were mandated for public disclosure. Medical institutions and pharmacies were instructed to cease selling and using any identified substandard drugs, while sales units were required to provide full refunds to consumers.

Company: https://www.globalkeysolutions.net/companies/hunan-wugan-pharmaceutical-co-ltd/9be9afed-2481-4fe7-931e-3518ac3c6d4c/
