Circular of the State Food and Drug Administration on self inspection of health food enterprises using ginkgo biloba extract (No. 26, 2015)

According to the requirements of the Circular of the State Food and Drug Administration on the verification of the use of illegal Ginkgo biloba extract to produce health food (No 22, 2015), the enterprises that use Ginkgo biloba extract to produce health food have carried out self inspection, and the relevant information is hereby notified as follows: 1 A total of 168 enterprises using ginkgo biloba extract to produce health food have submitted the self inspection Among them, 157 enterprises used ginkgo biloba extract to produce health food, and 11 enterprises held the approval number of health food using ginkgo biloba extract but did not produce it According to the inspection method in the notice on Issuing the supplementary inspection method for Ginkgo biloba drugs (No 66, 2015) issued by the State Food and drug administration, the enterprise self inspected 359 batches of Ginkgo biloba extract raw materials Among them, 328 batches are qualified, 13 batches are unqualified and 18 batches are still under inspection The unqualified raw materials of Ginkgo biloba leaf extract involve the following 8 health food enterprises: Dalian ShuangDi Technology Co., Ltd., Jiangsu qingyuankang Biotechnology Co., Ltd., Zhongshan branch of Zhuhai federal Pharmaceutical Co., Ltd., Harbin Pharmaceutical Group Pharmaceutical General Factory, Hangzhou Taihe Health Food Co., Ltd., Pan'an foreign trade Pharmaceutical Co., Ltd., Shandong Shenghai Health Food Co., Ltd Division, huixintang (Beijing) Biotechnology Co., Ltd Shenyang branch According to the self inspection of the above enterprises, 4847 kg of unqualified Ginkgo biloba extract raw materials have been found, 2257.02 kg of raw materials have been sealed up, 805.67 kg of raw materials have been destroyed, and 1784.31 kg of other raw materials have been used 2 25 batches of products with quality problems were found in 5 of the above 8 unqualified enterprises Among them: (1) the Pharmaceutical General Factory of Harbin Pharmaceutical Group produced "Harbin pharmaceutical brand ginkgo leaf soft capsule" with unqualified ginkgo leaf extract The two batches of products were inspected by the enterprise, all of which were products with quality problems The company purchased 2350kg of unqualified raw materials, sealed 1688.85kg and used the remaining 661.15kg The company has taken control measures for the products with quality problems Up to now, 5203.01 kg of products with quality problems have been sealed off the shelves and recalled (2) Hangzhou Taihe Health Food Co., Ltd produced Taihe ginkgo leaf capsule with unqualified ginkgo leaf extract One batch of products inspected by the enterprise is found to have quality problems The enterprise has purchased 60 kg of unqualified raw materials, destroyed 50 kg and used the remaining 10 kg The company has taken control measures for the products with quality problems, and has taken off shelves, recalled and destroyed 1325 bottles of products with quality problems (III) Pan'an foreign trade Pharmaceutical Co., Ltd of Zhejiang Province produced "Dasheng brand Suning capsule" with unqualified Ginkgo biloba extract, and the enterprise self inspected one batch of products, which were found to have quality problems The enterprise has purchased 50 kg of unqualified raw materials, destroyed 41 kg and used the remaining 9 kg 2420 bottles of products with quality problems produced by the enterprise have not been put on the market and have been completely destroyed (IV) Shandong Shenghai health care products Co., Ltd produced 5 products such as "Lishou brand weight loss capsule" by using unqualified Ginkgo biloba extract The enterprise self inspected 53 batches of the above products, 44 batches of products were qualified after inspection, and 9 batches were products with quality problems The enterprise has purchased 100 kg of unqualified raw materials and used them all The enterprise has taken control measures for the products with quality problems At present, it has recalled 45 kg of the products with quality problems and destroyed 10 kg (V) Shenyang Branch of huixintang (Beijing) Biotechnology Co., Ltd accepted the entrustment of huixintang (Beijing) Biotechnology Co., Ltd and Shanghai defengtang Biotechnology Co., Ltd to produce "Baqi brand Jinrui capsule" and "Jinmai brand Jinmai capsule" with unqualified Ginkgo biloba extract 14 batches of products are inspected by the enterprise, 2 batches are qualified, and 12 batches are products with quality problems The company has purchased 987 kg of unqualified raw materials and used them all The company has taken control measures for the products with quality problems, "Baqi brand Jinrui capsule" has not been sold on the market, "Jinmai brand Jinmai capsule" is being recalled by the entrusting party, and 1831 boxes of products have been recalled at present The provincial (District, city) food and drug regulatory authorities where the above-mentioned enterprises are located shall supervise the enterprises to complete the recall of products with quality problems before July 8, timely disclose the name, batch, flow direction, quantity and other information of recalled products to the public, and the provincial food and drug regulatory authorities where the enterprises are located shall notify the relevant provincial (District, city) food and drug regulatory authorities, and copy the national food and drug regulatory authorities General Administration of quality supervision 3 The food and drug regulatory authorities of all provinces (districts and cities) shall organize food and drug inspection institutions to conduct sampling inspection on all health food enterprises using ginkgo biloba extract to purchase raw materials of Ginkgo biloba extract and the single side health food produced by Ginkgo biloba extract within the administrative region in accordance with the inspection method in the Announcement No 66, 2015 of the State Food and drug administration, and at the end of July We will release the results of sampling inspection to the public and report the results to the State Food and drug administration Prior to this, if the enterprise finds any nonconformity in self inspection, it shall report to the local food and drug regulatory authority in a timely manner IV if the self inspection product of the enterprise using ginkgo biloba extract to produce health food is unqualified, it shall report the unqualified Ginkgo biloba extract to the local food and drug administration before July 10 in accordance with the notice on law enforcement inspection of the enterprise using ginkgo biloba extract to produce health food (No 15, 2015) issued by the State Food and drug administration Source 5 The State Food and drug administration is investigating the source of raw materials for unqualified Ginkgo biloba preparation enterprises Once it is found out that the health food manufacturers that purchase qualified Ginkgo biloba extract from their own sources have the behavior of purchasing raw materials from unqualified Ginkgo biloba extract manufacturers, they shall report to the local food and drug regulatory department (District, city) and explain to the society the reasons for their qualified self inspection of Ginkgo biloba extract raw materials Relevant provincial (District, city) food and drug regulatory authorities shall investigate whether there is any concealment Notice is hereby given Attachment: Notice of the State Food and Drug Administration of China on July 3, 2015, No.26, 2015 Doc