Circular of the food and Drug Administration on the inspection of Ginkgo biloba extract and Ginkgo biloba drugs

According to the notice on the inspection of Ginkgo biloba leaf extract and Ginkgo biloba leaf drugs (No 20, 2015) issued by the State Food and Drug Administration on June 8, the manufacturers of Ginkgo biloba leaf extract and ginkgo leaf drugs carried out self inspection in accordance with the supplementary inspection methods published by the State Food and drug administration The relevant information is hereby notified as follows: I 90 manufacturers of Ginkgo biloba extract, Ginkgo biloba leaves (including dispersible tablets) and Ginkgo biloba leaves capsule have inspected 5161 batches of Ginkgo biloba extract, Ginkgo biloba leaves (including dispersible tablets) and Ginkgo biloba leaves capsule products produced by the company since January 1, 2014, 2335 batches of unqualified products, accounting for all 45% of the batch (see Annex 1 for details) II There are 55 manufacturers with unqualified products detected in the self inspection report of the enterprise (see Annex 2 for details) Among them: (1) there are 30 unqualified enterprises in all batches, including Tianjin Yabao Pharmaceutical (14.22, 0.00, 0.00%) Technology Co., Ltd (32 batches of Ginkgo leaves), Tangshan fule Pharmaceutical Co., Ltd (95 batches of Ginkgo leaves), Zhuozhou dongle Pharmaceutical Co., Ltd (172 batches of Ginkgo leaves), Shanxi Qianyuan Pharmaceutical (46.800, 0.00), 0.00%) Group Co., Ltd (27 batches of ginkgo leaf dispersible tablets), Shanxi Pude Pharmaceutical Co., Ltd (3 batches of ginkgo leaf), Jilin Zhenghe Pharmaceutical Group Co., Ltd (15 batches of ginkgo leaf), Harbin Pharmaceutical Group Shiyitang pharmaceutical factory (15 batches of ginkgo leaf dispersible tablets), Changzhou Lanling Pharmaceutical Co., Ltd (15 batches of ginkgo leaf capsules), Jiangsu Runbang Pharmaceutical Co., Ltd (Ginkgo leaf) Leaf, 125 batches), Wuzhong, Jiangsu (30.38, 0.00, 0.00%) Pharmaceutical Group Co., Ltd Suzhou pharmaceutical factory (6 batches of gingko leaf), Jiangsu Feima Pharmaceutical Co., Ltd (84 batches of gingko leaf), Jiangsu Suzhong Pharmaceutical Group Co., Ltd (2 batches of gingko leaf), Pizhou Jinlong biochemical products Co., Ltd (1 batch of Yinxingye extract), Pizhou Juxin gingko biochemical products Co., Ltd (1 batch of gingko leaf extract), Pizhou Xinyuan Biological products Co., Ltd (Ginkgo biloba extract, 2 batches), Ningbo traditional Chinese Medicine Pharmaceutical Co., Ltd (Yinxingye extract, 33 batches), Jiangxi Huiren Pharmaceutical Co., Ltd (Ginkgo biloba leaf, 39 batches), China Resources Sanjiu (35.60, 0.00, 0.00%) (Huangshi) Pharmaceutical Co., Ltd (Ginkgo biloba capsule, 2 batches), Wan Bangde (Hunan) Natural Medicine Co., Ltd (Ginkgo biloba, 12 batches; Ginkgo biloba capsule, 37 batches), Hunan Fangsheng Pharmaceutical Co., Ltd (65.11, 0.00, 0.00%), Hunan Kangerjia Pharmaceutical Co., Ltd (Yinxingye extract, 2 batches), Guangdong Yili Luoding Pharmaceutical Co., Ltd (Ginkgo leaf, 7 batches), Guangdong Xinfeng Pharmaceutical Co., Ltd (Ginkgo leaf, 33 batches), Guangdong Global Pharmaceutical Co., Ltd (Ginkgo leaf, 17 batches), Guilin Honghui pharmaceutical Co., Ltd (Ginkgo leaf, 9 batches); Ginkgo leaf capsule, 5 batches), Guangxi banzhou Dakang Pharmaceutical Co., Ltd (Ginkgo leaf, 25 batches), Guilin Xingda Pharmaceutical Co., Ltd (Ginkgo leaf, 46 batches; ginkgo leaf extract, 11 batches), Haikou Qili Pharmaceutical Co., Ltd (Ginkgo leaf, 69 batches; ginkgo leaf extract, 3 batches), Hainan Jindao pharmaceutical factory (Ginkgo leaf, 5 batches), Hainan Haili Pharmaceutical Co., Ltd (Ginkgo Leaf Film, 21 batches) (II) 25 enterprises failed in some batches of products, including Beijing Sihuan Pharmaceutical Co., Ltd (Ginkgo biloba dispersible tablets, 14 batches unqualified, unqualified rate of 13.7%), Tianjin Taiyang Pharmaceutical Co., Ltd (Ginkgo biloba extract, 8 batches unqualified, unqualified rate of 25.0%), Hebei Tiancheng Pharmaceutical Co., Ltd (Ginkgo biloba leaves, 7 batches unqualified, unqualified rate of 41.2%), Heilongjiang Tianhong Pharmaceutical Co., Ltd Pharmaceutical Co., Ltd (Ginkgo leaf, 44 batches unqualified, unqualified rate 29.9%), Xuzhou Jiyuan Pharmaceutical Co., Ltd (Ginkgo leaf extract, 21 batches unqualified, unqualified rate 48.8%), Yangtze River Pharmaceutical Group Co., Ltd (Ginkgo leaf, 261 batches unqualified, unqualified rate 63.3%), Nanjing Yiheng Pharmaceutical Co., Ltd (Ginkgo leaf, 28 batches unqualified, unqualified rate 75.7%), Pizhou City Tianli Biotechnology Co., Ltd (Ginkgo biloba extract, 2 batches of unqualified, unqualified rate 66.7%), Jiangsu chenpai Pharmaceutical Co., Ltd (Ginkgo biloba leaves, 56 batches of unqualified, unqualified rate 96.6%; Ginkgo biloba dispersible tablets, 74 batches of unqualified, unqualified rate 96.1%), Ningbo Lihua Pharmaceutical Co., Ltd (Ginkgo biloba leaves, 5 batches of unqualified, unqualified rate 5.9%; Ginkgo biloba extract, 2 batches of unqualified, Unqualified rate: 4.3%), Wuhu Green Leaf Pharmaceutical Co., Ltd (Ginkgo leaf capsule, 57 batches unqualified, unqualified rate: 78.1%), Anhui Shengying Pharmaceutical Co., Ltd (Ginkgo leaf, 192 batches unqualified, unqualified rate: 95.5%; ginkgo leaf extract, 23 batches unqualified, unqualified rate: 92.0%), Yantai Rongchang Pharmaceutical Co., Ltd (Ginkgo leaf, 18 batches unqualified, unqualified rate: 12.0%), lunanhou General Pharmaceutical Co., Ltd (Ginkgo leaf, 11 batches unqualified, unqualified rate 91.7%), Shandong Baicao Pharmaceutical Co., Ltd (Ginkgo leaf capsule, 20 batches unqualified, unqualified rate 71.4%), Shandong Shuanghua Pharmaceutical Co., Ltd (Ginkgo leaf extract, 6 batches unqualified, unqualified rate 60.0%), Henan Wanxi pharmaceutical Co., Ltd (Ginkgo leaf, 5 batches unqualified, unqualified rate 62.5%), Jianmin Group (41.40, 0.00, 0.00%) yekai Thailand Pharmaceutical (Suizhou) Co., Ltd (Ginkgo leaf, 2 batches of unqualified, unqualified rate of 22.2%; ginkgo leaf dispersive tablets, 7 batches of unqualified, unqualified rate of 13.2%), Hunan Warner Pharmaceutical Co., Ltd (Ginkgo leaf, 15 batches of unqualified, unqualified rate of 75.0%; ginkgo leaf dispersive tablets, 87 batches of unqualified, unqualified rate of 74.4%), Chongqing Kerui Nanhai Pharmaceutical Co., Ltd (Ginkgo Leaf Extract, 10 batches of unqualified, unqualified rate 32.3%), Sichuan Kelun Pharmaceutical (45.50, 0.00, 0.00%) Co., Ltd (Anyue branch) (Ginkgo leaf, 24 batches of unqualified, unqualified rate of 32.0%), Chengdu Huagao Pharmaceutical Co., Ltd (Ginkgo leaf extract, 5 batches of unqualified, unqualified rate of 4.5%), Shenzhen Haiwang Pharmaceutical Co., Ltd (Ginkgo leaf, 174 batches of unqualified, unqualified rate of 95.6%; ginkgo leaf dispersible tablets, 14 batches of unqualified, unqualified rate of 100%), Guizhou Xinbang Pharmaceutical (18.86%) , 0.00, 0.00%) Co., Ltd (Ginkgo leaf, 68 batches of unqualified, unqualified rate of 73.9%), Guizhou Yibai Pharmaceutical (59.72, 0.00, 0.00%) Co., Ltd (Ginkgo leaf, 49 batches of unqualified, unqualified rate of 100%; ginkgo leaf extract all qualified) 3 35 enterprises that have passed the self inspection report, including Shijiazhuang Yiling Pharmaceutical (24.28, 0.00, 0.00%) Co., Ltd., Dalian Meiluo traditional Chinese Medicine Factory Co., Ltd., Changchun Overseas Pharmaceutical Group Co., Ltd., Jilin cross sea Biochemical Pharmaceutical Manufacturing Co., Ltd., Tonghua Jinma (8.47, 0.00, 0.00%) Pharmaceutical Group Co., Ltd., Shanghai Xinyi BaiLuDa Pharmaceutical Co., Ltd., Shanghai Xingling technology Pharmaceutical Co., Ltd., Jiangsu Enhua saide Pharmaceutical Co., Ltd., Jiangsu beisikang Pharmaceutical Co., Ltd., Jiangsu Kangyuan Pharmaceutical Co., Ltd (32.43, 0.00, 0.00%), Jiangsu MEITONG Pharmaceutical Co., Ltd., Jiangsu delikang Food Co., Ltd., Zhejiang Kangenbei (26.86, 0.00, 0.00%) Pharmaceutical Co., Ltd., Hangzhou Kangenbei Pharmaceutical Co., Ltd., Ningbo lvzhijian Pharmaceutical Co., Ltd., Zhejiang huisong Pharmaceutical Co., Ltd., Shandong Xianhe Pharmaceutical Co., Ltd., Shandong Lvyin Pharmaceutical Co., Ltd., Shandong Renhe Pharmaceutical Co., Ltd., Henan Lingrui Pharmaceutical Co., Ltd (14.83, 0.00, 0.00%) Co., Ltd., Luoyang Junshan Pharmaceutical Co., Ltd., Hubei noon Pharmaceutical Co., Ltd., Yuanda pharmaceutical Huangshi Feiyun Pharmaceutical Co., Ltd., Hubei nuokiter Pharmaceutical Co., Ltd., Hunan Hansen Pharmaceutical Co., Ltd (29.68, 0.00, 0.00%), Guangxi Yikang Pharmaceutical Co., Ltd., Guilin Huayi Pharmaceutical Co., Ltd., Guangxi jinshanzi Pharmaceutical Co., Ltd., Hainan Asia Pharmaceutical Co., Ltd., Chongqing Kerui Pharmaceutical (Group) Co., Ltd., Chongqing everything Chunsheng Pharmaceutical Co., Ltd., Chongqing Zhongbao Biological Pharmaceutical Co., Ltd., Sichuan Yuxin Pharmaceutical Co., Ltd., Yunnan Xitao Pharmaceutical Co., Ltd Green Pharmaceutical Co., Ltd., Chengdu Longquan high tech Natural Pharmaceutical Co., Ltd 4 The food and Drug Administration of each province (District, city) has carried out spot check on the self inspection results of relevant production enterprises A total of 595 batches of samples from 50 enterprises were randomly selected, accounting for 56% of the total number of enterprises in production and 12% of the total number of products The results of recheck and inspection are consistent with the results of self inspection V the above enterprises that have detected unqualified products have taken the initiative to stop selling and recall products The relevant provincial (District, city) food and drug regulatory authorities are requested to supervise the above-mentioned enterprises to complete the recall work before June 30, and timely disclose the recall information and recall results to the public Enterprises with all unqualified products shall expand the scope of recalled products to include the products manufactured before January 1, 2014 within the full validity period; enterprises with partial unqualified products shall carry out self inspection on the products manufactured before January 1, 2014 within the full validity period, and recall the unqualified products Self inspection and recall shall be reported to the local province (District, city) eclipse before July 10 Drug administration The enterprise drug recall related to the notice on illegal production and sale of Ginkgo biloba drugs by Guilin Xingda Pharmaceutical Co., Ltd (2015 No 15) and the notice on illegal sale of Ginkgo biloba drugs by Ningbo Lihua Pharmaceutical Co., Ltd (2015 No 17) by the food and drug administration has been basically completed before June 3 Vi if the drug distributors and users find the above-mentioned unqualified products, they shall immediately stop selling and using them and report to the local food and drug regulatory authorities For the unqualified drugs that consumers require to return, the relevant drug production and marketing enterprises and medical institutions shall, in accordance with the requirements of the notice of the food and Drug Administration on the effective recall of Ginkgo biloba drugs (sfdj [2015] No 9), recover all the drugs and refund them in full VII The enterprise that finds out the unqualified preparation product by self inspection shall report the reason of the unqualified product to the local food and drug administration before June 25 The preparation product manufacturer shall also report the source of Ginkgo biloba extract, including the name of the extract manufacturer, purchase time and quantity, used quantity and existing inventory quantity In case of purchase from a business enterprise, the local food and Drug Administration of the province (district or city) shall trace the source of purchase of the business enterprise, including the name of the production enterprise, the time and quantity of purchase, the destination and quantity of sales, the quantity of inventory, etc The above information shall be summarized and reported to the General Administration of food and Drug Administration of all provinces (districts and cities) before June 30 VIII According to the analysis of self inspection data, there are still some unapproved Ginkgo biloba extract manufacturers that have not reported the self inspection results The State Food and drug administration requires the enterprises that have not yet reported to immediately report the relevant situation and self inspection results to the local provincial (District, city) food and drug administration The food and drug regulatory departments of all provinces (districts and cities) shall strengthen supervision and inspection in accordance with the requirements of the notice of the food and Drug Administration on further improving the special treatment of Ginkgo biloba drugs (sfdj [2015] No 10) Enterprises that conceal information and do not take the initiative to conduct self-examination and self correction shall be strictly investigated and punished according to law IX in order to further confirm the quality status of Ginkgo biloba drugs in the market, the food and drug administration has deployed to comprehensively carry out the special supervision and sampling inspection of Ginkgo biloba drugs, and the sampling inspection will be announced to the public at the end of June Notice is hereby given Appendix: 1 Ginkgo biloba extract and Ginkgo biloba drugs