FDA Says Pfizer Plant in China Kept Two Sets of Quality Records, Used Expired Materials

FDA Says Pfizer Plant in China Kept Two Sets of Quality Records, Used Expired Materials

During an April inspection of Pfizer’s plant in the northern Chinese city of Dalian, U.S. Food and Drug Administration inspectors found that the plant kept a second set of quality and manufacturing records that didn’t match official records and that employees hid quality failures, used expired manufacturing materials or ones that hadn’t been recently checked, and retested failing products until they passed. [11/2/15]

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