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.
Details of the inspection were described in an FDA report called a Form 483 that was obtained by Bloomberg News. Mackay Jimeson, a Pfizer spokesman, confirmed Pfizer’s ownership of the plant....
...At Pfizer’s Dalian plant, the agency observed that when tests of drug products failed to meet standards, the same products were re-tested until passing results were achieved, and that the original failures were never reported or investigated.
The FDA inspectors also noticed that one manufacturing unit had only one stand-alone toilet in significant disrepair 50 yards from the aseptic manufacturing unit. Inside the facility inspectors saw no hand washing station and an open pit appeared to be used as a urinal.The open pit is a nice touch; I'd like to see the change control for the installation of that.