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FDA warns Pfizer over contaminated drugs at Kansas plant

FDA warns Pfizer over contaminated drugs at Kansas plant
From Reuters - February 28, 2017

The U.S. Food and Drug Administration said Pfizer Inc's process for manufacturing sterile injectable drugs at a plant in McPherson, Kansas was "out of control" and put patients at risk, according to a warning letter made public on Tuesday.

In the Feb. 14 letter, the FDA said that several productswere contaminated with multiple foreign particulates and that the injectable antibiotic vancomycin had been compromised by cardboard pieces.

It warned the company it had failed to take corrective action.

The presence of the foreign matter is "unacceptable" and suggests "a significant loss of control in your manufacturing process" that represents a "severe risk of harm to patients," the FDA wrote.

Pfizer said in a statement it has been "diligently implementing commitments made to the FDA" to ensure the agencys concerns are addressed.

The warning letter followed an investigation that took place between May 16 and June 8, 2016 into the facility in Kansas that Pfizer acquired with its $17 billion deal for Hospira in 2015.

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