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China to impose surprise inspection on drug and medical device companies

Xinhua, July 8, 2015 Adjust font size:

China will begin regular surprise inspections on pharmaceutical and medical device firms on September 1, according to China Food and Drug Administration (CFDA) on Wednesday.

A surprise check will be initiated without early notice to the companies and law enforcement will disclose no information about the process and problems spotted during the inspection, according to the CFDA.

When all the evidence has been collected and the nature of problems determined, local CFDA units will inform the manufacturers of rectification instructions.

Surprise checks will also be launched when authorities are contacted by whistle-blowers from the public or become suspicious of certain firms, said the CFDA.

The CFDA also stipulated restrictive rules on law enforcers with the drug administration. Any one found deliberately leaking confidential information on inspections or informers will be subject to discipline. Those involved with suspected criminal acts will also be transferred to judicial departments. Endi