3 Pharmaceutical Enterprises in Anhui Failed the Unannounced Inspection

December 08, 2014 By CPhI.cn

Anhui Food and Drug Administration conducted unannounced inspection on 13 manufacturing enterprises in TCM decoction pieces in Bozhou City on December 3 and 3 pharmaceutical product manufacturing enterprises had their GMP certificates taken back.

There were totally 79 items (times) of problems or defective items found in this unannounced inspection, for example, enterprises were found that their production outside the certified workshops was not conducted all-item inspection on the raw medicinal materials or finished products according to standards, the inspection reports were not true and the material management lacked standardization. Therein, 3 enterprises were serious in nature: Anhui Taiyuan Zhongyao Yinpian Youxian Gongsi was suspected of renting out pharmaceutical product production license and produced TCM decoction pieces by counterfeiting Anhui Guoxin Zhongyao Yinpian Co., Ltd.; "raw material warehouse" of Anhui Kanghui Pharmaceutical Co., Ltd. stored about 200pcs of TCM decoction pieces labelled as Bozhou Qiancao Pharmaceutical Co., Ltd., with a large number of unused packaging labels, packaging bags and one screening machine labelled as Bozhou Qiancao Pharmaceutical Co., Ltd., which was suspected of producing counterfeit TCM decoction pieces.

Anhui Food and Drug Administration has now asked Bozhou Food and Drug Administration to take back the pharmaceutical product GMP certificates of the 3 enterprises and investigate those enterprises' behaviors of violating laws and rules, and once they are suspected of crimes, they will be transferred to the public security organ; and instructed Bozhou Food and Drug Administration to talk with principals of the 9 enterprises violating stipulations of pharmaceutical product GMP to urge them to make rectification within a definite limit.