According to the clues provided by the report, on July 5, the State Food and Drug Administration and the Jilin Provincial Bureau conducted a flight inspection of Changchun Changsheng Company; on July 15, the State Food and Drug Administration and the Jilin Provincial Bureau formed an investigation team to conduct comprehensive investigations. On July 15, the State Food and Drug Administration issued the "Notice on Changchun Changsheng Biotechnology Co., Ltd.'s illegal production of freeze-dried human rabies vaccine."
It has been found that the company fabricates production records and product inspection records, and arbitrarily changes process parameters and equipment. The above acts are a serious violation of the relevant provisions of the Drug Administration Law of the People's Republic of China and the Regulations on the Quality Management of Pharmaceutical Production. The State Food and Drug Administration has ordered enterprises to stop production, recover the GMP certificate for drugs, and recall unused rabies vaccines. The State Food and Drug Administration and the Jilin Provincial Bureau have filed investigations on enterprises, and the suspected crimes have been transferred to the public security organs for criminal responsibility.
According to the relevant regulations on vaccine management, the vaccines for sale and marketing of all enterprises must be submitted to the China Food and Drug Control Research Institute for approval. The safety of all batches of vaccines should be tested during the batch issuance process, and the effectiveness of a certain proportion of batches of vaccines should be tested. . The company has been legally tested for the sale and use of vaccines, and no quality problems have been found. In order to further confirm the effectiveness of the vaccines already on the market, a laboratory evaluation of sample samples of enterprise samples has been initiated.
According to the monitoring by the Chinese Center for Disease Control and Prevention, the incidence of rabies in China has gradually declined in recent years.
The Food and Drug Administration has deployed national vaccine production enterprises to conduct self-inspection to ensure that enterprises organize production according to the approved technology, strictly abide by GMP production standards, and all production inspection process data should be true, complete, reliable and traceable. The State Food and Drug Administration will organize the flight inspection of all vaccine production enterprises, and seriously investigate and deal with violations of laws and regulations.
The person in charge said that the company was the second time in a year to discover the quality of product production. In October last year, the original food and drug supervision bureau found in the sampling test that the batch of Baibai broken vaccine produced by the company was unqualified, and the product is still in production. The former National Health and Safety Commission and the original food medicine are related to the replanting work. The General Administration of Supervision has deployed in February this year.
It has been found that the company fabricates production records and product inspection records, and arbitrarily changes process parameters and equipment. The above acts are a serious violation of the relevant provisions of the Drug Administration Law of the People's Republic of China and the Regulations on the Quality Management of Pharmaceutical Production. The State Food and Drug Administration has ordered enterprises to stop production, recover the GMP certificate for drugs, and recall unused rabies vaccines. The State Food and Drug Administration and the Jilin Provincial Bureau have filed investigations on enterprises, and the suspected crimes have been transferred to the public security organs for criminal responsibility.
According to the relevant regulations on vaccine management, the vaccines for sale and marketing of all enterprises must be submitted to the China Food and Drug Control Research Institute for approval. The safety of all batches of vaccines should be tested during the batch issuance process, and the effectiveness of a certain proportion of batches of vaccines should be tested. . The company has been legally tested for the sale and use of vaccines, and no quality problems have been found. In order to further confirm the effectiveness of the vaccines already on the market, a laboratory evaluation of sample samples of enterprise samples has been initiated.
According to the monitoring by the Chinese Center for Disease Control and Prevention, the incidence of rabies in China has gradually declined in recent years.
The Food and Drug Administration has deployed national vaccine production enterprises to conduct self-inspection to ensure that enterprises organize production according to the approved technology, strictly abide by GMP production standards, and all production inspection process data should be true, complete, reliable and traceable. The State Food and Drug Administration will organize the flight inspection of all vaccine production enterprises, and seriously investigate and deal with violations of laws and regulations.
The person in charge said that the company was the second time in a year to discover the quality of product production. In October last year, the original food and drug supervision bureau found in the sampling test that the batch of Baibai broken vaccine produced by the company was unqualified, and the product is still in production. The former National Health and Safety Commission and the original food medicine are related to the replanting work. The General Administration of Supervision has deployed in February this year.
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