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Pfizer's Chinese Plant Under Scrutiny from FDA

Pfizer's Chinese Plant Under Scrutiny from FDA


Drug manufacturing plant kept two sets of records, used old ingredients.

A Pfizer Inc., drug manufacturing plant in Dalian, China kept two sets of records and used old ingredients, according to Bloomberg News

The Food and Drug Administration found during an April inspection of the plant that it kept a second set of quality and manufacturing records that did not match official ones. In addition, the report said, the plant used expired materials, hid quality control failures, and retested failing products until they passed, according to Bloomberg

Pfizer confirmed to Bloomberg that they owned the plant, which is used to manufacture drugs shipped to the US, but that they were addressing the issues raised by the report. 

"The issues cited in the FDA Form 483 do not indicate any quality or safety concerns and do not have any impact on products currently on the market manufactured at the Dalian site," Pfizer spokesman Mackay Jimenson told Bloomberg. Jimenson also declined to state what drugs were manufactured at the site. 

The report, known as Form 483, was obtained by Bloomberg News and also included proof that plant employees literally moved stacks of documents and records from one room to another in an apparent effort to hide them from inspectors. When the inspectors requested the moved records, only a third were given to them. The remaining two-thirds, according to the report were removed and placed in a wooden crate in a different area from manufacturing.

Those moved records contained manufacturing information including temperature and humidity readings that did not match the official records inspected by the FDA. They also contained sticky notes explaining that some of the materials used were expired. 

The FDA also found that failing products were re-tested until they passed and no record that the initial failures were never reported. 

To make matters worse, hygiene at the plant also appeared to be in question. Inspectors, according to Bloomberg, noticed that the manufacturing unit "had only one stand-alone toilet in significant disrepair 50 yards from the aseptic manufacturing unit" and that inside the toilet "inspectors saw no hand washing station and an open pit appeared to be used as a urinal." 


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