State administration takes back GMP certificate of modified pharmaceutical industry (Liuhe plant) and Guangdong Yikang pharmaceutical

Source: Yuquan on November 16, 2014, conducted flight inspection on four enterprises producing Feining granule drugs in Jilin Province in cooperation with local food and Drug Administration on November 4-5, 2014 to revise the flight inspection of Pharmaceutical Group Co., Ltd (Liuhe plant area), and found that Xiuzheng Pharmaceutical Group Co., Ltd (Liuhe plant area) The raw materials stored in the stock for the production of Feining granules were mildewed and deteriorated, and the enterprises also deliberately fabricated false inspection reports The above behaviors have seriously violated the drug administration law and the relevant provisions of GMP At present, the General Administration has asked Jilin Provincial Bureau to withdraw its GMP certificate according to law, and seriously investigate and punish the illegal behaviors of the enterprise According to the flight inspection results of Guangdong Yikang Pharmaceutical Co., Ltd., it was found that there were trace antipyretic and analgesic anti-inflammatory drugs in the anti osteoproliferative tablets (batch No 120201) produced by Guangdong Yikang Pharmaceutical Co., Ltd On October 28-29, 2014, the General Administration of food and drug administration, together with the local food and drug administration, carried out flight inspection on Guangdong Yikang Pharmaceutical Co., Ltd and other enterprises After inspection, it was found that the product was entrusted to Shaoguan resident Pharmaceutical Co., Ltd for production Through the extended inspection of Shaoguan resident Pharmaceutical Co., Ltd., it was verified that there was cross contamination between the anti osteoproliferative tablets and the chlorphen Huang Min tablets in the production process of the enterprise This is a typical case of drug pollution caused by several entrusted production, alternating production of Chinese and Western medicine and incomplete site clearance The above behaviors have violated the drug administration law and the relevant provisions of GMP At present, Guangdong Provincial Bureau has taken back the GMP certificates of Guangdong Yikang Pharmaceutical Co., Ltd and Shaoguan resident Pharmaceutical Co., Ltd in accordance with the law In the process of further investigation and handling of the case, the product involved has started recall measures