SFDA Notice for the ilegal Production of Compound Loquat Particles by Sichuan Feideli Pharmaceutical Co., Ltd, Guangxi Tiantianle Pharmaceutical Co., Ltd. and Fujian Quanzhou Luoshangshan Pharmaceutical Factory (No. 46 of 2018)
SFDA have recently performed unnoticed inspection for Sichuan Feideli Pharmaceutical Co., Ltd, Guangxi Tiantianle Pharmaceutical Co., Ltd. and Fujian Quanzhou Luoshangshan Pharmaceutical Factory and we found that those three companies were guilty of illegal production problems , The notice is as follows:
Sichuan Feideli Pharmaceutical Co., Ltd first refused and tried to escape the inspection. On the very first day of inspection, they failed to provide key analysis equipment, computers and related data, until 16:00 the day after they managed to get us already scrapped analysis equipment and the data in USD flash drive. The data can not be traced either, and 11 batches of Campanulaceae medicinal herbs (slices) were tested from 2015 to 2017. However, the records of trace analytical balances have only been traced back to one batch. Purchases of Campanulaceae reference substance and platycodin D reference substance since 2013 have been significantly less for actual use, they allegedly failed to test according to the regulations
Guangxi Tiantianle Pharmaceutical Co., Ltd' production of compound loquat particles was not in accordance with prescription feeding, the prescription batch dosage for menthol should be 3.54kg, their actual feed volume was 0.1kg. They also made up fake related batch production record, also for related raw materials and excipients ledger, sub-ledger, QC sample sending and receiving records. The menthol quality control does not meet the requirements in the prescription, there are cases that menthol was released for production without testing. Menthol used production of snake bile Chuanbei liquid was sent for extract registration according to relevant provisions of regulations.
Fujian Quanzhou Luoshangshan Pharmaceutical Factory's feeding for compound loquat particles production was not in accordance with prescriptions, the actual purchase quantity was significantly less than the amount used. they faked the Menthol ledger and the original testing records, made up records for purchase, storage, testing and use records for 30kg menthol. There were cases that they used expired menthol for the production feeding for Compound loquat particles
The above-mentioned actions by Sichuan Feideli Pharmaceutical Co., Ltd, Guangxi Tiantianle Pharmaceutical Co., Ltd. and Fujian Quanzhou Luoshangshan Pharmaceutical Factory have seriously violated the relevant provisions in "drug production quality management standards" . SFDA requires Food and Drug Administration in Sichuan Province, Guangxi Zhuang Autonomous Region and Fujian to withdraw relevant "GMP certificates" for those three enterprises involved and investigate the alleged illegal production according to law.