China NMPA Drug Inspection - Haikou Qili Pharmaceutical Co., Ltd. - Ginkgo biloba extract

The State Food and Drug Administration (SFDA) of China, through Announcement No. 24 of 2015 published on June 22, 2015, detailed the findings of self-inspections conducted by 90 manufacturers of Ginkgo biloba extract and drugs. Mandated by SFDA Announcement No. 20 of 2015, these companies inspected products manufactured since January 1, 2014, using supplementary testing methods. A significant issue was identified: 2,335 out of 5,161 batches of products (45%) were found substandard. Fifty-five manufacturers reported defective products, with thirty companies having all tested batches fail quality standards, while twenty-five had some substandard batches. The regulatory framework required these self-inspections, followed by verification and ongoing special supervision by provincial food and drug administrations. As a result, companies with substandard products were directed to immediately cease sales and recall affected batches by June 30, 2015. This recall extended to all commercially available products manufactured before January 1, 2014, within their expiration date for companies with entirely failed batches. Manufacturers were also required to report the reasons for non-compliance and trace the source of their Ginkgo leaf extract by June 25th. Provincial authorities are to supervise these recalls and conduct further inspections. The SFDA also warned of severe penalties for non-compliance and concealment of information, signaling a comprehensive market sampling inspection to follow.