Compliance Management / Large Molecule / Small Molecule

FDA Slaps Chinese Pfizer Plant with Form 483

Nov 03, 2015

Bloomberg News

A Pfizer Inc. plant in Dalian, China, was inspected by FDA regulators for future drug shipments to the U.S. According to a Bloomberg article, the company kept a second set of quality and manufacturing records that didn’t match official ones.

During an April inspection, FDA inspectors reported that employees hid quality failures, used expired manufacturing materials or ones that hadn’t been recently checked, and retested failing products until they passed. Read the full story