Jiangxi food and Drug Administration announced the inspection of health food enterprises using ginkgo biloba extract

Notice of Jiangxi food and Drug Administration on inspection of health food enterprises using ginkgo biloba extract (No.1 in 2016) In accordance with the relevant requirements of the opinions of the State Food and Drug Administration on the disposal of the illegal use of unqualified Ginkgo biloba extract to produce health food (sfjzsjs [2016] No 22), our bureau organized the provincial food and Drug Inspection Bureau, Nanchang City, Zhangshu City and Yongxiu County food and Drug Administration to form a special inspection team to inspect the use of Ginkgo biloba extract in the whole province Enterprises that produce health food have carried out a comprehensive inspection Based on the special inspection of Ginkgo biloba extract carried out in 2015, the relevant information is announced as follows: 1 The variety of health food containing ginkgo biloba extract in Jiangxi raw materials According to the health food database of the General Administration of health care, there are four health food raw materials containing ginkgo biloba extract, namely, the serious brand Ginkgo Oral Liquid (wsjz (1999) No 0310) of Jiangxi serious Pharmaceutical Technology Co., Ltd., the Renhe brand zhiyaping capsule (wsjz (2002) No 0050) of Jiangxi Yaodu Renhe Pharmaceutical Co., Ltd., and Jiangxi Desheng Huimin Pharmaceutical Co., Ltd Xinmiaoxian capsule of Nanchang kangercong Health Products Co., Ltd (gsjz g2014048) and Yishengyuan gingko leaf Ganoderma lucidum spore oil soft capsule of Nanchang Tongxin Zichao Bioengineering Co., Ltd (gsjz g20150586) II Production, supervision and inspection of the enterprise (I) Jiangxi serious Pharmaceutical Technology Co., Ltd.: before June 1, 2015, gingko leaf extract of Jiangxi serious Pharmaceutical Technology Co., Ltd was purchased from Ningbo traditional Chinese Medicine Pharmaceutical Co., Ltd and Guangxi Changzhou Natural Pharmaceutical Co., Ltd According to the notice of the State Food and Drug Administration on the self inspection of 90 Ginkgo biloba extract and Ginkgo biloba drug manufacturers (No 24, 2015), 33 batches of Ginkgo biloba extract produced by Ningbo traditional Chinese Medicine Pharmaceutical Co., Ltd are not qualified by the enterprise self inspection Considering the potential quality and safety risks in the products, Jiangxi serious pharmaceutical science and Technology Co., Ltd initiated the recall procedure of serious brand ginkgo oral liquid, recalling 406 pieces and 7 boxes (10ml / bottle * 720 bottles / piece) The above products were destroyed under the supervision of Yongxiu food and Drug Administration from July 14 to 29, 2015 From June 1, 2015 to present, Ginkgo biloba extract of Jiangxi serious Pharmaceutical Technology Co., Ltd has been purchased from Hubei Knott Pharmaceutical Co., Ltd and Xuzhou Jiyuan Pharmaceutical Co., Ltd respectively During the on-site inspection by law enforcement personnel, it was found that the production process of Ginkgo biloba extract raw materials was not specified in the production process management system document of the enterprise, and the quality standard of Ginkgo biloba extract raw materials did not add the supplementary inspection method of free quercetin, kaempferol and isorhamnetin Law enforcement personnel ordered the enterprise to conduct the supplementary inspection according to the supplementary inspection method of free quercetin, kaempferol and isorhamnetin Method, to clarify the relevant process documents, raw material production process and quality standards (II) Jiangxi Yaodu Renhe Pharmaceutical Co., Ltd.: the Ginkgo biloba extract of Jiangxi Yaodu Renhe Pharmaceutical Co., Ltd was purchased from Chongqing Guoguang Natural Pharmaceutical Co., Ltd and Chongqing everything Chunsheng Biotechnology Co., Ltd Jiangxi pharmaceutical capital Renhe Pharmaceutical Co., Ltd has promised in writing that up to now, Renhe brand zhiyaping capsule has never been sold on the market Because the product registration application data does not reflect the production process of Ginkgo biloba extract, the law enforcement personnel ordered the enterprise to clarify the relevant process documents, raw material production process and quality standards in accordance with the supplementary inspection methods of free quercetin, kaempferol and isorhamnetin, and required Jiangxi yaoduren and Pharmaceutical Co., Ltd to submit a written report to Zhangshu City when resuming the production of Renhe zhiyaping capsule Quality supervision administration report (III) Jiangxi Desheng Huimin Pharmaceutical Co., Ltd.: the Ginkgo biloba extract of Jiangxi Desheng Huimin Pharmaceutical Co., Ltd was purchased from yanglingdong kemedison Pharmaceutical Co., Ltd Jiangxi Desheng Huimin Pharmaceutical Co., Ltd promises that Xinmiao heart capsule has never been sold on the market so far The law enforcement personnel ordered the enterprise to further clarify the production process of Ginkgo biloba extract in strict accordance with the relevant requirements of the State Administration, revise the relevant process procedures and quality standards of Ginkgo biloba extract, add "inspection items of free quercetin, kaempferol and isorhamnetin" to the inspection items in the quality standard of Ginkgo biloba extract, and indicate the content of Ginkgo biloba extract in the remarks The production process takes ethanol as the extraction solvent, and Jiangxi Desheng Huimin Pharmaceutical Co., Ltd is required to report in writing to Nanchang food and drug administration when resuming the production of xinmiaoxin capsule (IV) Nanchang Tongxin Zichao Bioengineering Co., Ltd.: the Ginkgo biloba extract of Nanchang Tongxin Zichao Bioengineering Co., Ltd is extracted by itself The law enforcement personnel found in the on-site inspection that the company failed to inspect the Ginkgo biloba extract according to the supplementary inspection method for free quercetin, kaempferol and isorhamnetin inspection items (approval No.: 2015001) The law enforcement personnel required the company to further clarify the production process of Ginkgo biloba extract in strict accordance with the relevant requirements of the State Administration In the quality standard of Ginkgo biloba extract, the inspection items of free quercetin, kaempferol and isorhamnetin were added, and the inspection requirements of Ginkgo biloba extract were strictly implemented Notice is hereby given Jiangxi food and Drug Administration April 19, 2016