China to Implement Surprise Inspections

In early July, the Chinese Food and Drug Administration (CFDA) announced that they will begin to conduct regular surprise inspections of pharmaceutical and medical device manufacturers starting on September 1, 2015.

In addition to the regular inspections, a manufacturer may also be targeted for a surprise inspection if the CFDA receives a tip-off from whistleblowers, hears of any problematic incidents, or becomes suspicious of the firm. The company targeted for inspection will not receive any prior notice. The CFDA will then inform the company of their inspection results after all the evidence has been gathered and analyzed.

The new inspection policy is intended to bolster the quality of pharmaceuticals and medical devices manufactured in China by enabling the CFDA to catch manufacturers before they can destroy any incriminating evidence. In order to ensure that the inspections are effective and kept a surprise, the CFDA has warned that punitive measures will be taken toward any official found leaking information about the inspections or any other confidential information.