5 pharmaceutical companies were investigated: 3 GMP were withdrawn and 2 licenses were revoked

It is learned from the drug administration of Guangxi Zhuang Autonomous Region, Shanxi Province, Guangdong Province, Xinjiang Uygur Autonomous Region and other four provinces (regions) that GMP of three pharmaceutical enterprises has been withdrawn, and one of them has been ordered to stop production and file a case for investigation Two pharmaceutical enterprises have been revoked their drug trading licenses On May 30, Guangxi Zhuang Autonomous Region, Shanxi Province and Guangdong Province drug regulatory bureau issued announcements respectively, and recovered GMP certificates of three pharmaceutical enterprises Among them, Guangxi Jinxiu Shengtang pharmaceutical industry, suspected of illegal activities such as production quality management confusion, forgery of batch production and other related records, was withdrawn GMP certificate, ordered to stop production and filed a case for investigation Foshan Yujia Herbal Pieces Co., Ltd was found two serious defects in the flight inspection, and the GMP certificate of herbal pieces was withdrawn, and was ordered to rectify Shanxi weikangtang Herbal Medicine Co., Ltd has seriously violated the provisions of the "drug production quality management specification" and withdrawn its "drug GMP certificate" in accordance with the provisions of Article 33 of the "drug production quality management specification certification management measures" Guangxi Zhuang Autonomous Region On May 30, the drug administration of Guangxi Zhuang Autonomous Region issued a notice that Guangxi Jinxiu Shengtang Pharmaceutical Co., Ltd withdrew its GMP certificate in accordance with the provisions of Article 55 of the measures for the administration of drug production supervision and Article 33 of the measures for the administration of drug production quality management and the measures for the Administration of drug production quality management Enterprise name: Guangxi Jinxiu Shengtang Pharmaceutical Co., Ltd drug production license No.: Gui 20160148 suspected of illegal activities: I production quality management confusion (I) no record of material requisition and distribution: Shuangshan granule extract stored in your company's cold storage has been collected but not recorded, and the warehouse keeper shall fill in a location card and submit it to law enforcement personnel during the inspection （2） There is no production order at the production site: the material cards of semi-finished products in the granulation / drying process of Shuangshan granules (batch No.: 20160203) under production at the site do not record the product batch number; the weighing room is temporarily changed to the granulation operation room; There are Shuangshan granules (batch No.: 20161201, 20160203) finished products stacked in the coating room or other production operation room at the site of the preparation workshop; the batch production of Shuangshan granules (batch No.: 20150603) extract does not match the production capacity （3） Personnel in key positions of production management are not on duty: during the inspection, it is found that after February 24, 2016, the production director and preparation workshop director of your company's key personnel have left the post, and Pang, the former warehouse keeper, is responsible for the production management, but the employee has no practical experience in drug production management and is not clear about the requirements of drug production management 2、 After verification of forged batch production and other relevant records, the batch production records, inspection records and finished product warehousing records of Shuangshan granules (batch No.: 20150504) provided by your company are all false records Handling measures: Guangxi Jinxiu Shengtang Pharmaceutical Co., Ltd has seriously violated the drug management law and the relevant provisions of GMP Guangxi Bureau takes back the GMP certificate of the enterprise, orders the enterprise to stop production, and files a case for investigation and punishment according to law for the illegal behaviors found Guangdong Enterprise Name: Foshan Yujia Herbal Pieces Co., Ltd production address: No.2, north of Pingshun West Road, Guicheng Street, Nanhai District, Foshan pharmaceutical production license No.: Yue 20160237 cause: main problems found due to inspection: There are 2 serious defects and 1 other problem in the production of Chinese herbal pieces (clean, cut, steamed, fried and baked), which do not meet the requirements of GMP Relevant information is summarized as follows: 1 Serious defects 2 （1） Some varieties have no batch production records, for example, 54 varieties such as chrysanthemum and almond produced from May 16 to May 19, 2016 have no batch production records （2） Some varieties (such as Sophora flavescens produced on May 14, 2016) were not inspected according to the quality standard 2、 The newly added production varieties of Chinese herbal pieces have not been reported to the food and Drug Administration of the city where they are located for filing If there are 120 registered varieties, there are 200 actual in-process products Treatment measures: 1 In view of the fact that the production of Chinese herbal pieces (purified, cut, steamed, fried and baked) of Foshan Yujia Chinese Herbal Pieces Co., Ltd does not meet the GMP requirements According to the relevant provisions of GMP management, the Provincial Bureau decided to withdraw the GMP certificate (Certificate No.: gd20150365) of the company's Herbal Pieces (prepared by purification, cutting, steaming, frying and roasting) 2、 Foshan food and drug administration is required to urge enterprises to rectify and strengthen daily supervision and variety record management Xinjiang Uygur Autonomous Region After investigation, Xinjiang Chengxing biomedical Co., Ltd and Xinjiang diyatai Biological Products Co., Ltd made false sales records and sales delivery lists The actual directions of vaccines were inconsistent with the sales records, and the tickets, accounts and goods were inconsistent The circumstances were serious Their behaviors seriously violated the relevant provisions of the drug administration law of the people's Republic of China and the drug quality management specifications According to the provisions of Article 78 and Article 84 of the drug administration law of the people's Republic of China, it is decided to revoke the drug trade licenses of the two enterprises mentioned above after research.