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Channel: DR ANTHONY MELVIN CRASTO Ph.D – New Drug Approvals
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FDA Says Chinese Pfizer Plant Hid Failures, Used Old Ingredients

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Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL:


October 31, 2015 — 2:22 AM IST,

The Pfizer Ltd. research and development plant in Dalian, China.
Bernardo De Niz/Bloomberg

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.

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