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FDA warns Pfizer Inc. of “significant violations” at a manufacturing plant


pfizer logoLast month, the United States Food and Drug Administration sent a letter to pharmaceutiucal company, Pfizer, Inc., warning of “significant violations” at a Hospira manufacturing plant.

Pfizer acquired Hospira in a $17 billion deal in 2015. An inspection was conducted from May to June of 2015 at a McPherson, Kansas Hospira drug plant, and the inspection cited “significant violations of current good manufacturing practice.” Further observations included the potential for contamination of sterile products, failure to appropriately respond to contaminated drug products within the facility, and “significant loss of control in [the] manufacturing process and…a severe risk of harm to patients.”

The FDA’s letter also stated that similar and additional violations were found at a number of other Hospira facilities. The FDA wrote to Pfizer that, “These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate.”

A Pfizer spokeswoman claims that the FDA’s concerns are not related to any Pfizer products currently on the market. “Patient safety is of primary importance to Pfizer, and the company is committed to ensuring the safety and quality of our medicines,” she said. These claims of committment to to safety and quality appear to be false, however, considering that Pfizer received complaints from the FDA on three separate dates (Dec 2015, Feb 2016, April 2016) regarding contamination of an injectable antibiotic called vancomycin. It wasn’t until May 2016, over four months after receiving the first complaint, that the company finally recalled the contaminated drug.

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Joe Messa

Joe MessaJoe Messa is the founder of Messa & Associates, a results-oriented personal injury law firm comprised of New Jersey and Philadelphia attorneys who specialize in medical malpractice, product liability, catastrophic injury, motor vehicle accidents, brain injury, birth injury, and burns, fires, and explosions. Messa & Associates holds a distinguished record of multi-million dollar verdicts and settlements for catastrophically injured clients, including but certainly not limited to: a $120 million Products Liablity settlement, an $85 million Premises Liability verdict, a $35 million Work Injury settlement, a $28.7 million Motor Vehicle Accident verdict, and a $16.5 million Medical Malpractice verdict.View all posts by Joe Messa →

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