4 medical equipment companies in Anhui failed to pass inspection | 557 rectification within a time limit

On October 31st, the medical network was suspected of using medical devices that exceeded the expiration date. The procurement records were incomplete. The company did not set up the warehouse according to the application project...' On October 29, the Food and Drug Administration announced the medical device supervision and inspection information. Among the 2,535 medical device companies examined, 557 were rectified within a time limit, and 4 were unqualified.

The inspection scope covers the whole province. medical instruments Production, management enterprise And the use unit; the inspection form is daily inspection, follow-up inspection and special inspection. The inspection found that two units were unqualified, namely Fengtai Longhua hospital Established various quality management records; Shouqiao Shuangqiao Town Center Health Center is suspected of using medical equipment that exceeds the validity period. One production enterprise and one operating enterprise are unqualified, respectively, Wuhu Shunda Denture Processing Factory purchase Incomplete records, no intermediate quality control records and material inbound and outbound records; Huangshan Shitejia Eye Clinic Co., Ltd. did not set up warehouses according to the application project. The above unqualified enterprises were found in the daily inspection of food and drug supervision law enforcement personnel.

During the inspection, there were 557 units or enterprises that were ordered to rectify because of various management defects: For example, the acceptance record of the Health Center of Lushan Town, Qijiang County is not standardized; the equipment of Huaibei Changzheng Rehabilitation Hospital is incomplete, and the maintenance record is incomplete; health Some legal qualifications of the supply unit of Science and Technology Co., Ltd. have not been updated in time; 3 refrigerators in the Inspection Department of the 17th Metallurgical Hospital of Ma'anshan have not registered the temperature and humidity records; Xuantong Women and Children's Hospital has not established a corresponding management system, and relevant records and information are incomplete; Cloud glasses business line Qiupu Road branch does not set medical equipment counters and so on.