Report that a pharmaceutical company has been fined 150,000! Another drug company was fined 420,000 for failing to make the difference in loading

Photo One of the pharmaceutical companies was fined because of the report, and the other pharmaceutical company was fined for failing to qualify for the difference in the amount of kidney capsules.
The following is a summary of the administrative penalty: ▍ report, Guizhou Houde Fenghua Pharmaceutical Co., Ltd. was fined 150,000 November 13, 2019, this Council received a report letter on the illegal and illegal production of Chinese medicine tablets, in 2019 From November 18 to November 20, 2019, the parties to carry out drug GMP tracking (for reasons) inspection, found that the parties suspected of illegal and illegal production of Chinese medicine tablets, this Council on March 26, 2020 filed a case .
Upon further investigation, between November 2018 and November 2019, the parties increased the crushing process in the production process of five varieties, such as money grass, winter grass, snow grass, soybean yellow roll, magpie fruit, resulting in non-compliance with the finished product features;
the time of the case on November 18, 2019, money grass, winter grass, snow grass, soybean yellow roll, magpie fruit five varieties produced a total of 8 batches of 135905 bags.
purchased by the sliced two batches of Lingzhi each 2000 kg, one batch produced a total of 3 batches of 321209 bags, did not carry out finished product inspection, audit release and sales, the other batch of uninsted production.
inspection and investigation, the above-mentioned money grass, winter grass and other 6 varieties of sex items do not meet the "Chinese Pharmacopoeia" (2015 edition) and other standards, but the safety and effectiveness of the product has not been affected.
also found that between April 2019 and May 2019, the parties carried out therattan crushing process in a production workshop that did not pass GMP certification, and by the time of the case on November 18, 2019, a total of 887 bags of Chinese medicine tablets had been produced
The six varieties of chinese medicine tablets produced by the parties, such as the above-mentioned money grass and winter ling grass, do not conform to the standards of the Chinese Pharmacopoeia (2015 edition), and in accordance with Article 98 (3) of the Drug Administration Law of the People's Republic of China (2019 as amended), "if there are any of the following circumstances, they shall be inferior medicines" and "other drugs that do not meet the drug standards".
" is qualitatively inferior.
The production of Chinese medicine tablets of six varieties, such as money grass and winter ling grass, which do not meet the drug standards, violates Article 44 (2) of the Drug Administration Law of the People's Republic of China (revised in 2019) "Chinese medicine drink tablets shall be made in accordance with the national drug standards;
" and article 98, paragraph 1, "prohibit the production (including preparation, the same between), sale, use, counterfeit drugs, inferior drugs."
"; In violation of Article 43 of the Drug Administration Law of the People's Republic of China (revised in 2019), "To engage in drug production activities, we shall abide by the quality management norms of drug production, establish and improve the quality management system for drug production, and ensure that the whole process of drug production continues to meet the statutory requirements."
".
If the six varieties of Chinese medicine tablets produced by the parties do not meet the drug standards, the safety and effectiveness of the products have not been affected, according to Article 117 (2) of the Drug Administration Law of the People's Republic of China (revised 2019), "If the Chinese medicine tablets produced and sold do not meet the drug standards and do not affect the safety and effectiveness, they shall be ordered to make corrections within a specified period of time and be given a warning; In accordance with Article 126 of the Drug Administration Law of the People's Republic of China >> (as amended in 2019), "Except as otherwise provided in this Law, drug market license holders, pharmaceutical production enterprises, pharmaceutical operating enterprises, drug non-clinical safety evaluation institutions, drug clinical trial institutions, etc. fail to comply with the drug production quality management norms, drug management practices, drug non-clinical research quality management norms, drug clinical trials, etc., Order a correction within a specified period of time and give a warning;"
In line with the principle of equal penalties, punishment and education, this Council has decided to order the parties concerned to correct the violation and to give the following administrative penalties: 1.warning;
▍ the production of inferior drugs kidney meta-capsules case, was fined 420,000 Guizhou Kidney Yuan Pharmaceutical Co., Ltd. production of the batch number 20200401 kidney meta-capsules, "check" under the load difference does not meet the requirements, qualitatively inferior drugs.
In view of the company in the production process of this batch of kidney metacapsules, the company fulfilled the raw material supplier audit, Chinese herbal medicine inspection, raw material audit release, product inspection, finished product audit release and other related obligations, no subjective intent to produce inferior drug kidney capsules, after the case to actively correct illegal acts, actively take the recall of unqualified drugs, carry out deviation investigation and other measures to control the risk of hidden dangers, the actual use of kidney metacapsules involved The number is small, did not find the use of the kidney metacapsules involved in adverse reactions, during the investigation and evidence collection in this Council, your company actively cooperate with the investigation and evidence collection work, actively provide relevant evidence materials, taking into account the facts of your company's illegal acts, nature, the extent of social harm and other factors, in line with the implementation of administrative penalties, correction of illegal acts, should adhere to the principle of equal punishment, punishment and education, your company has mitigating circumstances.
this Council decided to order your company to correct the illegal acts, and your company to give the following administrative penalties: 1, confiscation of inferior drugs kidney capsules 4415 boxes; 2, the confiscation of illegal income amounting to RMB 10,000 to Zero Wu-ting (RMB 13050.00); 3. And the value of the goods amount of RMB wanton pick-up of 10,000 yuan or slugs (¥41220.00) double the fine of RMB pick-up of 10,000 yuan (¥412,200.00) or more of the total amount of fines of RMB pick-up or Million Wu Yuwu (¥425,250.00)