SFDA Notice for Shanxi Yunpeng Pharmaceutical Co., Ltd. and other two manufacturers suspected of illegal production of drugs (No. 45 of 2018)
State Food and Drug Administration recently has tracked and inspected Shanxi Yunpeng Pharmaceutical Co., Ltd., Shanxi Hua Wei Pharmaceutical Co., Ltd. and Hainan Yishun Pharmaceutical Co., Ltd. We found that those three companies above were suspected for illegal production problems, the notice is as follows:
1. YunPeng pharmaceutical co., LTD, Shanxi Yunpeng Pharmaceutical Co., Ltd has data reliability problems.Also the test data can not be traced, the original records, spectrums, data and calculation process were missing, management for production and test records very choatic, random disposal of stamped CoA, original blank record for test and production . Deviation investigation and corrective & preventive measures do not meet related requirements.Medicine sampling substandard: cystine tablets, piroxicam tablets, indomethacin enteric-coated tablets, deviations in the production process was not investigated but finished products were released for sale. The computer system for analytical instruments is not subject to authority management and control.
2. Taiyuan Huawei Pharmaceutical Co., Ltd, related problems:The existence of fake testing data. Chinese medicine injection, herbs, medicinal reference substance have exactly the same Spectrum, very big chance they are the same Sprectrum without comparison by testing. The released ethanol and benzyl alcohol lacked the Reference infrared spectrum, without performing effective infrared identification according to the Chinese Pharmacopoeia (2015 edition). File management very chaotic, random abandonment and disposal of signed release note and CoA. The computer system for analytical instruments is not subject to authority management and control.
3.Hainan Yishun Pharmaceutical Co., Ltd. without registration approval, has added excipients hydroxypropyl cyclodextrin into propyl gallate for injection prescription, and since year 2015 when factory put into production, propyl gallate for injection has been manufactured and sold without process validation.
The aforesaid acts of Shanxi Yunpeng Pharmaceutical Co., Ltd., Shanxi Huawei Pharmaceutical Co., Ltd. and Hainan Yishun Pharmaceutical Co., Ltd. seriously violated the relevant provisions of the "Code of Quality Control for Pharmaceutical Production". The State Food and Drug Administration requested Food and Drug Administration in Shanxi and Hainan Province to withdraw the relevant "Drug GMP Certificate" of the involved enterprises and investigate the suspected illegal activities of the enterprises according to law.