China NMPA Drug Inspection - Tangshan Fule Pharmaceutical Co., Ltd. - Ginkgo leaves

From June 16 to 25, 2015, China's State Food and Drug Administration (SFDA) conducted a special supervision and sampling inspection of Ginkgo Leaf drugs, leading to significant findings under its regulatory framework. Out of 284 batches tested, 67 (23.6%) were found substandard, involving 24 pharmaceutical manufacturers. A key issue identified was discrepancies in self-inspection. Four companiesHeilongjiang Tianhong Pharmaceutical, Jilin Kuahai Biochemical, Ningbo Lihua Pharmaceutical, and Hunan Huana Pharmaceuticalhad products that passed their internal quality checks but failed the SFDA's market surveillance. This indicated inconsistencies between their retained samples and the products sold to consumers. These companies were required to immediately recall the affected batches and re-inspect all previously cleared products from the market, with results due by July 10th. Furthermore, thirteen companies, including Guilin Xingda Pharmaceutical and Shenzhen Haiwang Pharmaceutical, were cited for incomplete recalls of previously identified substandard Ginkgo Leaf drugs, despite earlier SFDA announcements and deadlines. Their continued presence on the market highlighted inadequate self-inspection and recall processes. The SFDA mandated these companies to complete comprehensive recalls of all substandard products by July 10th, with provincial authorities instructed to intensify supervision. The SFDA also ordered in-depth investigations into the four companies with self-inspection discrepancies, focusing on potential evidence alteration or evasion. While most manufacturers' self-reports were deemed reliable and market cleanup efforts showed results, these inspections underscored the need for rigorous quality control and full compliance with recall directives.