Summary of 34 reasons and measures for rectification of 390 mechanical enterprises

On June 29, the Anhui Food and Drug Administration issued the "Anhui Food and Drug Administration Medical Device Supervision and Inspection Information Notice (May 2016)". The notice shows that in May 2016, the provincial drug supervision department targeted the province. 1039 medical device production units, business units, and users used daily inspections, special inspections, and follow-up inspections, including 4 follow-up inspections, 886 daily inspections, and 148 special inspections.

It is understood that there are 689 business units and operating enterprises inspected in the province in May, 23 production units and production enterprises, and 326 units of use.

After investigation, there were 645 qualified inspections, 9 unqualified, and 381 rectified within a time limit. As a result, 390 companies were unqualified and rectified within a time limit, accounting for 37.54% of the total inspections.

In the unqualified and limited time rectification measures, a total of 64 items were involved, and 34 items appeared in the May inspection. The Chinese medical equipments are organized as follows:

1. The sanitary environment of the laboratory is poor; the management of medical device management personnel is unfamiliar, and the storage of devices is unreasonable.

2. Some medical devices do not provide purchase receipts and supplier qualification certificates, and are required to provide deadlines.

3, laboratory reagents without cold chain process temperature record

4. Filing and investigation, some medical devices cannot provide legal bills

5. There is no file for the use of large-scale equipment, and no medical device quality management organization has been established.

6, the instrument has not been accepted, no temperature record in transit, no maintenance

7. Suspected of using expired medical equipment, filing a case

8, request three types of medical equipment purchase information

9, the claim is not complete

10. The supplier's power of attorney was not requested from the supplier.

11. The glass ionomer cement sampled on site cannot provide registration certificate.

12. The site failed to provide bills and qualifications, and did not accept and maintain.

13. Incomplete inspection records, medical equipment and in-transit temperature records, incomplete bills, and expired qualifications

14. Acceptance record is incomplete

15. Medical equipment purchase acceptance records are not timely

16, medical equipment purchase acceptance records are not timely, no custom denture traceability records have been established

17. The medical device purchase acceptance record is not timely; the claim is not timely

18. The medical device purchase acceptance record is not timely; the claim is not complete.

19. Medical equipment is not stored according to the specified conditions, and the investigation is handled.

20. Order to inspect and record and submit annual self-examination report according to regulations.

21. Order to submit annual self-examination report according to regulations

22, ordered to establish medical equipment purchase inspection records

23. Order to submit the self-examination report immediately, complete the inspection record of the purchase, and save the original data of the three types of medical equipment according to the regulations.

24. Order to submit annual self-examination report and save medical device usage records as required

25. Order to submit annual self-examination report and establish a sound inventory inspection record

26. Order to submit annual self-examination report and establish incoming inspection record

27. Order to submit annual self-examination report, establish incoming inspection records, and save the purchase of three types of medical equipment original materials according to regulations.

28. Order to submit the annual self-examination report, establish the inspection record of incoming goods, and save the original data of medical equipment purchased according to regulations.

29. Order to submit annual self-examination report, establish incoming inspection records, and save medical device usage records according to regulations.

30. Order to submit annual self-examination report, complete the inspection record of the purchase, and save the record of medical device use according to regulations.

31. Order to submit self-examination report and save medical device usage records as required

32. Order to submit a self-inspection report, calibrate, verify and save the maintenance records of the applicable medical devices as required.

33. Order to submit self-examination report, establish incoming inspection record, and save the original information of medical equipment purchased according to regulations.

34. Order to submit self-examination report, fill in the inspection record, and save the medical device usage record according to regulations.

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