The State Food and Drug Administration recently issued a notice that 14 batches of drugs produced by 11 companies were found to be non-compliant after inspection by 4 drug inspection institutions including the Shanghai Food and Drug Inspection Institute.
According to the notice, after inspection by the Shanghai Institute of Food and Drug Inspection, the three batches of tacrolimus ointment marked as Shandong Ruian Pharmaceutical Co., Ltd. commissioned by Chifeng Wanze Pharmaceutical Co., Ltd. did not meet the regulations, and the non-compliant items were related substance. Related substances refer to the organic impurities in the drug, which are indicators reflecting the purity of the drug. The main sources are impurities brought in during the preparation process and impurities produced by the degradation of the drug during storage or transportation.
According to the inspection by China National Institutes for Food and Drug Control, one batch of Olopatadine Hydrochloride Eye Drops marked as produced by Zhejiang Jianfeng Pharmaceutical Co., Ltd. did not meet the regulations, and the non-compliance item was the filling volume. Filling capacity is an indicator reflecting the weight or capacity of the drug, and is applicable to solid, semi-solid, and liquid preparations. Failure to comply with the regulations will lead to insufficient clinical dosage.
After inspection by the Shenzhen Institute of Drug Control, the first batch of fried silkworms marked as produced by Shanxi Kangyi Hengtai Pharmaceutical Co., Ltd. did not meet the regulations. The items that did not meet the regulations were traits and total ash content. The properties of Chinese herbal medicines do not meet the requirements, which may involve deviations in the species of medicinal materials, flawed processing techniques, improper storage, etc. The purpose of total ash determination is to detect the purity of traditional Chinese medicine.
Inspected by Zhejiang Food and Drug Inspection Institute, it is marked as Hebei Runhua Pharmaceutical Co., Ltd., Hebei Kangyiqiang Pharmaceutical Co., Ltd., Anhui Xusong Chinese Medicine Pieces Co., Ltd., Anhui Zehua Chinese Medicine Pieces Co., Ltd., Shandong Qianhe Chinese Medicine Pieces Co., Ltd. Company, Chengdu Hexiangtian Pharmaceutical Co., Ltd., Yulin Guangjitang Traditional Chinese Medicine Development Co., Ltd., and Xinjiang Enze Traditional Chinese Medicine Pieces Co., Ltd. produced 9 batches of fried jujube kernels that did not meet the regulations, and the non-compliant item was water. Moisture refers to the water content in the drug product. High moisture is usually related to factors such as craftsmanship, improper packaging, and storage and transportation environment.
The State Food and Drug Administration stated that for the above-mentioned drugs that do not meet the regulations, the drug supervision and management department has required relevant enterprises and units to take risk control measures such as suspension of sales and use, recalls, etc., to investigate the reasons for the non-compliance and make effective rectification. The State Food and Drug Administration requires the relevant provincial drug supervision and management departments to organize investigations into suspected illegal activities 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 regulations.
Source: State Food and Drug Administration official website