Pfizer Inc. PFE received a warning letter in lieu of flowers from the FDA on Valentine’s Day.
A drug manufacturing facility owned by the pharma giant — Hospira Inc. in McPherson, Kansas — was found during inspections made in 2016 to have violated multiple regulations, according to the federal agency.
Multiple Regulation Violations
The errors include a failure to properly investigate “visible particulates” found in injectable drugs, which the FDA said “represents a severe risk of harm to patients.”
The particulates in at least three cases were found by Pfizer to have been cardboard, according to the letter.
Pfizer bought Hospira for $17 billion in 2015.
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Pfizer submitted a corrective and preventive action plan to the FDA at the time of the inspection of its Kansas facility, spokeswoman Rachel Hooper said Tuesday.
“Since the inspection, the McPherson site has been diligently implementing commitments made to the FDA,” Hooper said. “We will continue to identify assessments and potential corrective actions to ensure the FDA’s observations are addressed.”
The problems outlined in the FDA letter do not affect any Pfizer products from the McPherson plant available on the market now, according to Pfizer.
Companies that receive such letters must respond within 15 days and investigate the violations named by the FDA, determine their cause and prevent their recurrence.
Failure to correct FDA violations can result in legal action and the withholding of approval of drug applications tied to the facility, the agency said.
In one case, Pfizer recalled vials of antibiotic vancomycin hydrochloride more than four months after receiving a complaint and determining the medicine was contaminated with cardboard.
“Extrinsic contaminants, such as cardboard, pose a significant risk to patients and indicate that your process for manufacturing sterile injectable products is out of control,” the FDA said.
Other violations cited in the FDA letter deal with sterility procedures, a lack of defect limits for visual inspections and the drug manufacturing facility’s process for quarantining potentially defective materials.
The FDA has also issued similar violations at other Pfizer-owned facilities in the United States, India, Australia and Italy within the last seven years; the agency said, “These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate.”
Hooper said the company is focused on safety, stating, “Patient safety is of primary importance to Pfizer, and the company is committed to ensuring the safety and quality of our medicines.”
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