Certificate lost, 48 Enterprises may not have a happy National Day holiday

On the day before the National Day holiday (September 30), the food and Drug Administration of Shandong, Hubei, Hunan, Chongqing, Shaanxi and other provinces (cities) issued a series of announcements, 48 pharmaceutical companies lost their certificates The details are as follows: Shandong: 2 GMP certificates, 17 GSP certificates, 4 gsp14 GMP certificates Two pharmaceutical manufacturers, Shandong Xianhe Pharmaceutical Co., Ltd and Shandong kongshengtang Pharmaceutical Co., Ltd., have seriously violated the provisions of the pharmaceutical production quality management specifications According to the provisions of Article 33 of the administrative measures for the certification of pharmaceutical production quality management specifications, our bureau has withdrawn its GMP certificate in accordance with the law, which is hereby announced List of GMP certificate withdrawal (2016 No.3) 17 GSP certificates withdrawn 14 GSP certificates withdrawn Hubei: 1 GSP certificate withdrawn, 7 GSP certificates withdrawn Eight enterprises, such as Hubei Dekang Pharmaceutical Co., Ltd., Hubei harmonious Pharmaceutical Co., Ltd and Wuhan Xinli Pharmaceutical Co., Ltd., violated the "quality management specification for drug distribution" Hubei food and Drug Administration revoked the "certificate of quality management specification for drug distribution" of Wuhan xinyingde Biological Products Co., Ltd according to law, and took back the GSP certificates of the other seven pharmaceutical enterprises Revoking GSP certificate, 1 taking back GSP certificate, 7 Hunan: revoking GSP of 4 pharmaceutical enterprises Four enterprises, Hunan Tianding Pharmaceutical Co., Ltd., Hunan Xiekang Pharmaceutical Co., Ltd., Hunan Fuding Tianda pharmacy chain Co., Ltd and Xiangxi Kaiming pharmacy retail chain Co., Ltd., have been shut down for a long time and do not have the conditions for drug handling enterprises Our bureau plans to cancel the drug handling license and drug handling quality management standard certification of the above four enterprises in accordance with the law Certificate If the above-mentioned enterprises have any objection, they shall appeal to our bureau within one month from the date of promulgation of this announcement, and our bureau will be deemed as having no objection within the time limit Basic information of the enterprises planning to cancel the drug trade license and the certificate of drug trade quality management standard According to the requirements of CFDA's Announcement No 94 in 2016, during the special rectification flight inspection for illegal operation of drug wholesale enterprises, Chongqing Yifang Pharmaceutical Co., Ltd was found to have seriously violated the "quality management specifications for drug operation" and had significant risk of drug operation quality and safety In order to strengthen risk prevention and control, in accordance with the provisions of Article 25 of the measures for flight inspection of pharmaceutical and medical devices (Order No 14 of the State Food and Drug Administration), our bureau has revoked its certificate of quality management standard for pharmaceutical trading in accordance with the law, which is hereby promulgated Shaanxi: the GSP of one pharmaceutical enterprise was revoked, and one Lintong company of Xi'an traditional Chinese medicine group and Xi'an Yuchuang Pharmaceutical Co., Ltd were withdrawn due to their serious violation of the "drug management quality management specification" Shaanxi food and Drug Administration decided to revoke the former's GSP certificate and the latter's "drug operation quality management specification certificate" Cancel 1 GSP certificate and withdraw 1 GSP certificate