Six other medical machinery companies were notified by the State Food and Drug Administration and ordered to rectify
Medical Network November 1st, October 30, the State Drug Administration issued a centralized inspection result of nine medical device manufacturers. The inspection found that some enterprises have a number of general defects, and the provincial drug regulatory authorities instructed enterprises to rectify within a time limit. .
On-site inspection found that Chifeng Kyushu Tongda medical instruments There are many luminaire damages in the company, which can not provide proper lighting. The semi-finished assembly workshop, the relative humidity of the assembly workshop does not meet the requirements of the clean room relative humidity should be controlled at 45%-65%; the initial contamination of the product and the detection of particulate contamination are not determined. The trend analysis cycle, the collected test data did not perform statistical analysis and other 13 general defects.
Tianjin Yangquan Medical Instrument Co., Ltd. has no pending inspection and return area in the production raw material warehouse; no review, verification and confirmation records for changing part of the tank production process from outsourcing to injection molding; Set 12 general defects such as sampling points of the total water supply.
Hangzhou Huqing Yutang Pharmaceutical Technology Co., Ltd. has a 'unqualified product bank' used as a utility room; some quality records are not standardized or incomplete; the "Product Retention Observation System" does not clearly observe the sample observation and inspection items, and fails to provide 10. Keep the sample and other 10 general defects.
Hunan Hengtian Biotechnology Co., Ltd. has no return or recall area in the finished product warehouse;purchase The contents of the control program are incomplete; 95% of the medical alcohol supplier's procurement records have no general defects such as inspection reports and acceptance criteria.
Sino-British Anocon (Ningxia) Biotechnology Co., Ltd. has irregular management of the materials used in the R&D department, and does not accurately record the quantity issued; the standards and records for the process inspection of the cutting process are not established; In the middle, there are 15 general defects such as the reagent lot number information used.
Shanghai Yiyou Medical Devices Co., Ltd. has not revised the document control procedures in time; the supplier audit system is not perfect; enterprise The program file tracks and analyzes customer feedback information and other 7 general defects.
For the problems found in the inspections of the above six companies, relevant provincial level drug The regulatory department shall instruct the enterprise to rectify within a time limit, follow up the review if necessary, and require the enterprise to assess the product safety risks. If there is a potential safety hazard, the relevant products shall be recalled in accordance with the “Administrative Measures for Medical Device Recall”.
In addition, the on-site inspection also found that Xi'an Biomedical Engineering Co., Ltd., Chuxiongzhou Medical Appliance Co., Ltd., Guangxi, Guangxi medicine The Science and Technology Medical Products Factory has stopped production, and should be inspected by the relevant drug regulatory authorities before returning to production.
