[Medicine heaven and earth] 3.15 a holiday is around the corner. FDA has these actions

3.15 in the near future, what are the flight inspection and verification trends of CFDA and local drug administrations in all provinces and cities last week? The editor made a summary for you Let's see the following: CFDA General Administration reported that six pharmaceutical enterprises were accepted into GMP on March 5, and the State Food and Drug Administration issued two notices to announce the situation of six pharmaceutical enterprises suspected of illegal production of drugs In the near future, the State Administration of pharmaceutical industry has carried out follow-up inspection / flight inspection on six pharmaceutical enterprises, including xiyunpeng Pharmaceutical Co., Ltd., Shanxi Huawei Pharmaceutical Co., Ltd., Hainan Yishun Pharmaceutical Co., Ltd., Sichuan fideli Pharmaceutical Co., Ltd., Guangxi tiantianle Pharmaceutical Co., Ltd and Fujian Province Quanzhou luochangshan pharmaceutical factory It is found that the above-mentioned enterprises are suspected of illegal production problems and requires the local province to The bureau took back the relevant GMP certificates of six enterprises involved and investigated their suspected illegal activities according to law On March 8, Guangdong food and Drug Administration issued the second notice on the information of drug spot check and inspection in 2018 60 batches of 52 varieties of drugs failed to meet the requirements of drug standards after inspection, including 57 batches in use and 3 batches in use GSP removed On March 6, the Shenzhen municipal market and quality supervision and Administration Commission of Guangdong Province issued the notice on revoking the GSP certificate The drug dealers in shangshuijing No.1 Branch of Shenzhen ruicaotang pharmacy Co., Ltd seriously violated the provisions of the drug trade quality management specification, and their drug trade quality management specification certificate was revoked, and their credit rating was assessed as "serious" Dishonesty " Illegal facts of two pharmaceutical enterprises have been disclosed Two pharmaceutical enterprises in Foshan City, Guangdong Province have been publicly punished for producing / selling inferior drugs On March 6, Foshan Municipal Food and Drug Administration issued the information disclosure form of the fourth case in 2018, and the traditional Chinese medicine Yinpian factory of Guangdong pharmaceutical company has been punished for producing unqualified drugs "myrrh" On March 9, the market supervision and management information network of Shunde District of Foshan City released the first public form of administrative punishment information in March 2018 Longjiang Xixi branch of Foshan Mingren Pharmaceutical Co., Ltd was ordered to correct the illegal act for suspected sale of inferior drugs "Baihe" and "Dilong" On March 6, a pharmaceutical company was found to have six non-compliance facts Guangzhou drug regulatory bureau of Guangdong Province issued the first notice on drug GSP rectification within a time limit in 2018, ordering Guangdong Minsheng Tang Pharmaceutical Co., Ltd to make rectification within a time limit On March 7, the illegal drug advertisements of Guangxi 4 were published The food and Drug Administration of Guangxi Zhuang Autonomous Region released the advertisements of illegal drugs, medical devices and health food, and published the advertisements of illegal drugs, medical devices and health food in December 2017 On March 7, the food and Drug Administration of Guangxi Zhuang Autonomous Region issued a notice on drug quality (phase 2, 2018) Three batches of pharmaceutical preparations and one batch of Chinese herbal pieces did not meet the requirements of the standard On March 6, the sale of yizuxin Shuxin granules was suspended The food and Drug Administration of Guangxi Zhuang Autonomous Region issued a notice In the advertisement of "yizuxin Shuxin granules" produced by Yunnan Mingding Pharmaceutical Co., Ltd., there were some contents that seriously deceived and misled consumers, such as exaggerating product indications (functional indications), which were suspended in Guangxi Anhui 10 kinds of drugs are unqualified! On March 9, Anhui food and Drug Administration issued the second issue of "Anhui drug quality announcement" in 2018 10 varieties and 10 batches of drugs failed to meet the requirements of the standard, among which one batch of samples was qualified in the supervision and sampling inspection The items that failed to meet the requirements included [property], [inspection] water content, weight difference, filling amount difference, dissolution rate, [extract] and [content determination] On March 9, 2012, 12 drug manufacturers will be randomly selected Anhui Provincial Food and Drug Administration issued the work plan of 2018 "double random and one open" directional spot check 12 drug manufacturers, 4 special drug distributors and 20% drug wholesalers undertaking vaccine distribution business in 2018 will be randomly selected These pharmaceutical companies will be fly tested! On March 8, Anhui Tongling drug regulatory bureau issued the implementation plan for flight inspection of drug handling enterprises in 2018 The objects of inspection are as follows: 100% coverage of flight inspection for drug wholesale enterprises in the city, 50% coverage of flight inspection for headquarters of drug retail chain enterprises in the city, and no less than 10% coverage of flight inspection for drug retail enterprises in the city Zongyang County and Yi'an District Bureau determine the coverage rate of flight inspection for drug chain and retail enterprises within their jurisdiction by themselves In principle, the objects of inspection are randomly selected, but those with one of the following situations are directly taken as the objects of inspection: (1) enterprises with low level of daily management and disordered channels of purchase and sale; (2) enterprises with complaints and reports or clues indicating the existence of quality and safety risks; (3) An enterprise that frequently changes its business license Guizhou Province is suspected of serious violations of discipline On March 9, a deputy director of the food and drug administration was investigated The supervision committee of Guizhou Provincial Commission for Discipline Inspection announced that Luo Xiangbin, a member of the Party group and deputy director of Guizhou food and drug administration, was subject to review and investigation Luo Xiangbin, a member of the Party group and deputy director of Guizhou food and drug administration, is suspected of serious violations of discipline and law, and is currently subject to discipline review and supervision investigation On March 7, 2018, Hainan pharmaceutical regulatory bureau issued the notice of withdrawal of GMP certificate No 1, and Hainan Yishun Pharmaceutical Co., Ltd was withdrawn its GMP certificate (Certificate No.: hi20170024) On March 7, four pharmaceutical companies in Shanghai were required to make rectification within a time limit Shanghai Qingpu District market supervision and Administration Bureau issued the circular on administrative inspection information of drug retail enterprises in this district (February 2018), and four enterprises made rectification within a time limit On March 7, Hubei pharmaceutical enterprises will be seriously discredited in 7 cases Xiaogan pharmaceutical regulatory bureau of Hubei Province printed and issued the measures for the assessment and application of safety credit rating of pharmaceutical trading enterprises in Xiaogan City (for Trial Implementation), which will come into effect on March 10, 2018, with a validity period of 2 years The seven cases that are determined as serious dishonesty are as follows: 1 The license is revoked according to law due to the violation of laws and regulations on drug supervision and administration; 2 The license is ordered to suspend business by the supervision and administration department due to its serious illegal behavior; 3 The license is included in the Joint Disciplinary list by other departments; 4 The license is put on file by the supervision and administration department due to its illegal behavior; 5 Forging and altering administrative license, registration certificate, entry-exit quarantine certificate, approval certificate, inspection report, etc., and providing false certification materials or concealing facts to the food and drug administration department when applying for administrative license; 6 The person in charge of the enterprise and the person directly responsible for the crime of drug safety are subject to criminal treatment; 7 Others who have subjective intention to sell fake and inferior drugs, and the circumstances are abominable and the harm is serious On March 7, two pharmacies in Jiangxi sold substandard drugs The market and quality supervision and Administration Bureau of Xinyu City, Jiangxi Province issued the information disclosure form of administrative penalty cases of food and drugs in Jiangxi Province (February 2018), which announced the administrative penalty information of two pharmacies, Xinqing pharmacy on Beihu East Road, Yushui district and Likang pharmacy in Xinyu high tech Zone Illegal facts of two pharmaceutical enterprises in Shandong Province have been disclosed On March 6, the drug administration of Heze City, Shandong Province issued the publication of administrative penalty information (February) Jinhua drugstore of Heze Zhongyuan drugstore chain Co., Ltd never purchased drugs from individuals with drug handling qualification, confiscated its illegal income of 1374 yuan and fined 2748 yuan according to law The wholesale Department of Heze Peony Pharmaceutical Co., Ltd did not handle drugs according to the drug handling quality management standard A fine of 12000 yuan will be imposed for local transformation and sale of drugs to others without qualification On March 6, the GMP of Shanxi No.2 pharmaceutical company was collected Shanxi Provincial Food and Drug Administration issued the announcement No.33 of 2018 on the withdrawal of GMP certificate, and the GMP certificate of Shanxi Yunpeng Pharmaceutical Co., Ltd and Shanxi Huawei Pharmaceutical Co., Ltd was withdrawn On March 6, the inspection of 18 batches of drugs in Shaanxi Province failed to pass the inspection The drug administration of Shaanxi Province issued the drug quality announcement of Shaanxi Province, which announced the 18 batches of drugs found in the sampling inspection that did not conform to the regulations The items that did not conform to the regulations were mainly properties, identification, inspection, content determination, etc On March 5, a pharmaceutical enterprise was fined for producing fake drugs in Beijing Huairou District drug regulatory bureau of Beijing Municipality issued the second phase of information disclosure of administrative punishment cases against infringement, counterfeit and shoddy drugs in 2018 Yanbei Yinpian factory in Beijing was fined for producing fake drugs Jiangsu 2 drug and 2 device illegal advertisement is announced On March 5, Jiangsu Provincial Food and Drug Administration issued the advertisement announcement of illegal drugs, medical devices and health food in December 2017 The illegal advertisements such as zideng capsule of Yunnan Longfa Pharmaceutical Co., Ltd., Sanbao capsule of Jilin jurentang Pharmaceutical Co., Ltd., high potential therapeutic machine of Shanghai Xingrui Biotechnology Co., Ltd and far-infrared blood activating and pain killing paste of Shaanxi Renkang Pharmaceutical Co., Ltd were Publish On March 5, 20 pieces of traditional Chinese medicine in Gansu Province were under key supervision Gansu Provincial Drug Administration issued a notice and issued the list of key supervision varieties of traditional Chinese medicine in the first quarter of 2018, including 20 varieties such as alum, Mianma Guanzhong, yam and seaweed Content source: CFDA, local food and drug administration, pharmaceutical intelligence data, local medical platform, medical observer network, Cyprian blue, etc