FDA Says Chinese Pfizer Plant Hid Failures, Used Old Ingredients

[proverbialwisdom]

Source: Bloomberg News

October 30, 2015 — 1:52 PM PDT


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

> Records show FDA inspected plant in northern China in April
> Plant was inspected for future shipping to U.S., Pfizer says

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.

“Pfizer has responded and addressed the issues raised during a pre-approval inspection of our manufacturing site at Dalian,” Jimeson said in an e-mailed 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.”

Read more: http://www.bloomberg.com/news/articles/2015-10-30/fda-says-chinese-pfizer-plant-hid-failures-used-old-ingredients

[Demeter]

1. I am not in the least bit surprised

Pfizer is scum, China is criminally negligent: together they spell DEATH.

[BlueJazz]

2. A spokes-person said: "Do not have any impact on profits..ah..products currently on the market"

[StoneCarver]

3. We can't import Rx from Canada

"because it's not safe". But look where their made -India and China! I would never take a medicine made in China -ever! (No offense to Chinese people. It's the system)
Stonecarver

[A Simple Game]

4. How can you tell where they were made? I looked at my prescription bottle and it doesn't say.

When the TPP passes none of this will matter, take your medicine and like it or leave it.

[stuffmatters]

5. I read yesterday that Pfizer is in the process of "inverting" by buying an Irish Corp

Pfizer is already near the top of tax evading corps offshoring and tax cheating Americans billions ..now they're going IRS full monty. Yet they will retain their major and insatiable seat at the trade agreement tables.

And I see that the Senate is in the process of negating "Country of Origin" labels to please the WTO and obey NAFTA ISDS. Given
Pfizer's power...even though they are not going to even be a tax paying US Company... surely our State Department will support their inevitable demands to erase "country of origin" labels from Chinese meds. Sickening.

[Kang Colby]

6. I wonder if Pfizer had someone at least smell the stuff...

before they used it. Sometimes the sell by date has past, but it still smells ok.