FDA Says Chinese Pfizer Plant Hid Failures, Used Old Ingredients
- Records show FDA inspected plant in northern China in April
- Plant was inspected for future shipping to U.S., Pfizer says
The Pfizer Ltd. research and development plant in Dalian, China.
Bernardo De Niz/BloombergThis article is for subscribers only.
A Pfizer Inc. plant in China that was being inspected by Food and Drug Administration regulators in order to ship drugs to the U.S. kept a second set of quality and manufacturing records that didn’t match official ones, according to an FDA review of the facility.
During an April inspection of Pfizer’s plant in the northern Chinese city of Dalian, FDA inspectors said in their report that employees hid quality failures, used expired manufacturing materials or ones that hadn’t been recently checked, and retested failing products until they passed.