China NMPA Drug Inspection - Chongqing Kerui Nanhai Pharmaceutical Co., Ltd. - Ginkgo biloba extract

The State Food and Drug Administration (SFDA) of China published Announcement No. 24 of 2015 on June 22, 2015, detailing the findings of self-inspections conducted by 90 manufacturers of Ginkgo biloba extract and related pharmaceutical products. The inspections, covering 5,161 batches produced since January 1, 2014, revealed that 2,335 batches, representing 45% of the total, were substandard based on supplementary testing methods. Fifty-five companies reported non-compliant products. Among these, 30 companies, including Tianjin Yabao Pharmaceutical Technology Co., Ltd. and Zhuozhou Dongle Pharmaceutical Co., Ltd., had all their inspected batches fail to meet quality standards. Another 25 companies, such as Yangtze River Pharmaceutical Group Co., Ltd. and Shenzhen Haiwang Pharmaceutical Co., Ltd., reported a significant portion of their batches as substandard. In response, the SFDA mandated that all implicated manufacturers immediately cease sales and recall affected products. Companies with entirely substandard products were ordered to recall all commercially available stock produced before January 1, 2014, within its expiration date. Manufacturers with partially substandard products were required to conduct further self-inspections and recall any non-compliant batches. Provincial food and drug authorities were tasked with supervising these recalls, with a primary completion deadline of June 30th and reporting due by July 10th. Furthermore, companies were required to report the reasons for non-compliance and provide detailed traceability of their Ginkgo leaf extract sources by June 25th to ensure comprehensive market oversight.