China NMPA Drug Inspection - Hainan Zhuotai Pharmaceutical Co., Ltd. - Ginkgo leaf medicine

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.