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FDA alleges records cover-up at Chinese Pfizer plant

Published on 03/11/15 at 08:20am
China manufacturing
The FDA alleges irregularities during an inspection at a Pfizer plant in China

The FDA has discovered violations at a Pfizer plant in China, including the use of out-of-date materials and record- keeping that did not match official FDA records.

According to a Bloomberg report, FDA inspectors visited the plant in April and discovered that plant workers hid quality failures and performed repeat tests on products until they passed. The FDA also says the plant used expired materials or ones which had not recently undergone quality checks, which amounts to intentionally misleading FDA inspectors.

It is alleged that workers moved or hid documents while the inspectors were on-site at the facility. FDA officials apparently found a large stack of documents, which had been removed when they returned to their location just 10 minutes later. When they requested the documents, a factory official only returned some of the papers.

FDA inspectors say in the report filed: “We then requested an interview with the individual responsible for the removal of the documents, and found that he had removed the remaining stack from the manufacturing area and placed them in the upper-floor construction/expansion area within a wooden crate.”

The documents removed are said to be a set of manufacturing records which include manufacturing batch numbers of drug materials, temperature and humidity conditions, and manufacturing yield- none of which match the plant’s official manufacturing records that were also inspected by the FDA.

Inspectors said they also found sticky notes within these documents, which said drug manufacturing materials were expired or past the date where they needed to be re-tested.

Pfizer spokesperson Mackay Jimeson declined to comment on which products are manufactured at the plant, but did confirm the company’s ownership of the facility.

“Pfizer has responded and addressed the issues raised during a pre-approval inspection of our manufacturing site at Dalian,” Jimeson says in a statement. “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. Patient safety is of utmost importance to Pfizer, and Pfizer is committed to ensuring the safety and quality of our medicines.”

Joel Levy

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