The State Food and Drug Administration on 4 batches of drugs
Notification of non-conformity
(65 of 2023)
After the inspection of 4 drug inspection institutions including the Guizhou Provincial Food and Drug Inspection Institute, it was found that 4 batches of drugs did not meet the regulations. The relevant situation is hereby notified as follows:
1. According to the inspection of the Guizhou Provincial Food and Drug Inspection Institute, the 1 batch of anti-uteritis tablets taken from Chongqing Jianganfang Pharmaceutical Co., Ltd. did not meet the requirements, and the non-compliant items were microbial limits.
According to the inspection of the Shanghai Institute for Food and Drug Control, one batch of tacrolimus ointment taken from Sinopharm Tianhe Jilin Pharmaceutical Co., Ltd. did not meet the requirements, and the non-compliant items were related substances.
According to the inspection of the Shenzhen Institute for Drug Control, the 1 batch of fried zombie silkworms taken from the Chunyuantang clinic did not meet the regulations, and the non-compliant items were total ash.
According to the inspection of Qinghai Provincial Drug Inspection and Testing Institute, 1 batch of boiled licorice taken from Nagqu Huimin Hospital did not meet the requirements, and the non-compliant items were content determination.
2. For the above-mentioned non-compliant drugs, the drug regulatory department has required relevant enterprises and units to take risk control measures such as suspension of sales and use, recall, etc., to investigate the reasons for non-compliance and effectively carry out rectification.
3. The State Drug Administration requires the relevant provincial drug regulatory departments to organize an investigation into the suspected illegal acts of the above-mentioned enterprises and units in accordance with the Drug Administration Law of the People's Republic of China, and disclose the results of the investigation and punishment in accordance with the regulations.
Notice is hereby given.
Annex:
1.4 List of non-compliant drugs for batches
2. Minor knowledge of non-compliant items
State Food and Drug Administration
December 6, 2023
Source | Yunnan market supervision WeChat public account