Medical network on April 28 - in the middle of April, 2017, state administration of drug safety continue in Beijing, tianjin, liaoning, guangdong, jiangsu, gansu the several provinces and cities spread medical instrument flight inspection work.
The flight tests included both the inspection and the GMP compliance inspection. Total flew to check 10 medical device manufacturing enterprise, the results there are three serious defects was ordered to close immediately. There are seven general defects was ordered to make correction.
In addition to the six medical devices that the fda has inspected in March, the general administration has already reached 16 in the year.
Here are the details of the flight inspection:
Beijing, Beijing, China, and medical instruments co., LTD. : a deadline for rectification
Product name: arsenic trioxide drug-coated stent delivery system
Purpose of inspection: compliance inspection
Defect details:
Yi sheng technology (Beijing) co., LTD. : a deadline for rectification
Product name: drug-eluting coronary stents
Purpose of inspection: compliance inspection
Defect details:
Sano medical science and technology co., LTD. : a deadline for rectification
Product name: biodegradable drug-coated coronary stent system
Purpose of inspection: compliance inspection
Defect details:
Liaoning China biotechnology co., LTD. : a deadline for rectification
Product name: balloon expansion catheter
Purpose of inspection: compliance inspection
Defect details:
5, hua big gene biotechnology (shenzhen) co., LTD. : a deadline for rectification
Product name: foetal chromosome (T121, T18, T13) test kit (semiconductor sequencing)
Purpose of inspection: compliance inspection
Defect details:
Haichang contact lens co., LTD. : a deadline for rectification
Product name: soft wet contact lens
Purpose: to check
Defect details:
Gansu convision technology group co., LTD. : a deadline for rectification
Product name: soft wet contact lens
Purpose: to check
Defect details:
Beijing natural beauty optics co., LTD. : stop production and repair
Product name: soft wet contact lens
Purpose: to check
Defect details:
Jiangsu Helen contact lens co., LTD. : immediately stop production and repair
Product name: soft water contact lens, contact lens lubricant
Review purpose: to check:
Defect details:
Guangzhou corfu eyeglasses co., LTD. : immediately stop production and repair
Product name: soft wet contact lens
Purpose: to check
Defect details:
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