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    Home > Medical News > Medical World News > Recall, destroy and punish the inferior drugs produced by pharmaceutical enterprises!

    Recall, destroy and punish the inferior drugs produced by pharmaceutical enterprises!

    • Last Update: 2020-01-08
    • Source: Internet
    • Author: User
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    Editor: Dandelion Yuxuan On January 7, the official website of drug administration of Guangxi Zhuang Autonomous Region released a decision on administrative penalty (gyjysf [2019] No 8) According to the decision, Shuanghuang Xiaoyan tablets (batch No 180301 and 180401) of Guangxi Ritian Pharmaceutical Group Co., Ltd were randomly inspected by Jilin Provincial Institute of drug control [inspection] and [weight difference] and were judged as inferior drugs, and were punished twice Fines and confiscations totaled over 130000 yuan If according to the new drug administration law, two batches of 2 million! On January 6, Shandong Provincial Drug Administration issued a letter of decision on administrative punishment The traditional Chinese medicine factory of Shandong hongjitang Pharmaceutical Co., Ltd was fined twice for the result of "alcohol insoluble substance" due to the exhaustion of Chinese herbal pieces The total fine was 161055 yuan If the new drug administration law is followed, 1 million penalties will be imposed Jilin Institute of pharmaceutical inspection has issued three inspection reports The production unit is Shuanghuang Xiaoyan tablets (batch numbers 180301 and 180401) of Guangxi Ritian Pharmaceutical Group Co., Ltd after inspection, the inspection item [inspection] item [weight difference] does not meet the requirements On July 18, 2019, the law enforcement personnel of the drug administration of the autonomous region, accompanied by the production principal of the company, conducted on-site inspection on the warehouse, extraction workshop, production workshop, finished product warehouse, sample retention room, laboratory and other places of Guangxi Ritian Pharmaceutical Group Co., Ltd according to law The warehouse does not have these two batches in stock Check the quality department, check the production, inspection, warehousing and other related records of the products involved in the case, 180301 batches, 17160 boxes of Shuanghuang antiphlogistic tablets (package specification: 10 tablets / plate × 4 plates / box) 180401 batches, 22870 boxes of Shuanghuang Xiaoyan tablets (package specification: 10 tablets / plate × 3 plates / box) Sales: the two batches are all sold, and the sales prices are 1.67 yuan / box and 1.82 yuan / box respectively On September 17, 2019, the enterprise submitted these two batches of recall summary reports to Guangxi Zhuang Autonomous Region drug administration The report shows: 180301 batches, all of which have been sold on the market, without drug recall; 180401 batches, 3606 boxes recalled in total, and the recall work on the market has been completed Recall drugs, supervised by marketing Bureau: Liuzhou market supervision and Administration Bureau came to the company for supervision and inspection on October 18, 2019, and supervised the destruction of 1508 boxes of Qinghuozhimai capsule (batch number: 170601), 1507 boxes of Shuanghuang Xiaoyan tablets (batch number: 190301) and 3602 boxes of Shuanghuang Xiaoyan tablets (batch number: 180401) in the boiler area of the company This case is a general administrative case The company actively cooperates with the law enforcement personnel in the on-site inspection, meanwhile, the parties actively carry out the rectification to find out the causes and take preventive measures According to the provisions of Article 27, paragraph 1 (1), of the administrative penalty law of the people's Republic of China, our bureau decides to punish the company's above-mentioned violations lightly According to the provisions of item (6), paragraph 3, Article 49 of the drug administration law of the people's Republic of China (revised in 2015), it shall be punished as inferior drug according to law In view of the fact that the recalled drugs have been destroyed, the party concerned shall be given the following administrative penalties: (1) The illegal income from the sale of Shuanghuang Xiaoyan tablets (batch No.: 180301 and 180401) was confiscated as RMB 63612.08; (2) A fine of 70000 two hundred and eighty yuan and sixty cents (¥ 70280.60) twice of the value of Shuanghuang Xiaoyan tablet (batch No.: 180301 and 180401) was imposed, that is, 70000 two hundred and eighty yuan and sixty cents (¥ 70280.60) The total amount of the above fines and confiscations: one hundred and thirty-three thousand eight hundred and ninety-two point sixty-eight (¥ 133892.68) Screenshot of website of Shandong Drug Administration On January 6, Shandong Provincial Drug Administration issued a letter of decision on administrative penalty The traditional Chinese medicine factory of Shandong hongjitang Pharmaceutical Co., Ltd was fined a total of 161055 yuan for unqualified products On June 5, 2019, Shandong food and drug inspection and Research Institute (SFDA) selected the Chinese herbal medicine dried blood (Lot No.: 20190101) from the Chinese herbal medicine factory of Shandong hongjitang Pharmaceutical Co., Ltd as the marked manufacturer After the inspection by Gansu drug inspection and Research Institute, the result of "alcohol insoluble substance" did not meet the standard After reinspection by CFDA, the "alcohol insoluble" item of this batch of Dracaena Draconis does not meet the national drug standard The Chinese medicine factory of Shandong hongjitang Pharmaceutical Co., Ltd did not meet the national drug standard of Dracaena Draconis (batch No.: 20190101) and violated the relevant provisions of the drug administration law Shandong drug regulatory bureau decided to punish the Chinese medicine factory of Shandong hongjitang Pharmaceutical Co., Ltd as follows: 1 Confiscate 15.77kg Draconis with the batch number of 20190101; 2 Confiscate the illegal income of 53685 yuan; 3 In addition, a fine of 107370 yuan will be imposed for two times of the value of goods (53685 yuan) The total amount of fines and confiscations is 161055 yuan.
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