FDA issues warning letter to Pfizer

The FDA highlight particulate contamination and inadequate aseptic techniques as areas of significant concern at a former Hospira facility

The regulation authority said there were “significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals” at the facility in a warning letter dated February 14 2017.

The FDA inspection was conducted at a McPherson drug plant in Kansas, during three weeks between May and June last year. Pfizer acquired the plant with its approximately $17 billion takeover of Hospira in 2015.

The FDA reviewed reports from multiple investigations the facility conducted into complaints regarding the presence of visible particulates in several sterile injectable products.

“The presence of visible particulates in sterile injectable products is an indication of a significant loss of control in your manufacturing process and represents a severe risk of harm to patients,” stated the FDA.

“We documented that your investigations into these product quality defects were inadequate and failed to spur appropriate corrective actions and preventive actions.”

The warning letter cited an example of a complaint of particulate matter in a vial (containing vancomycin hydrochloride for injection), which the company determined was cardboard, probably related to the handling of their vial stoppers.

“The presence of visible particulates in sterile injectable products represents a severe risk of harm to patients.

However, the company “closed the investigation without a comprehensive evaluation of the extent of the contamination and without taking further corrective actions.”

“The presence of multiple foreign particulates in your products is unacceptable. 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,” wrote the FDA.

During the inspection, and FDA investigator also observed the introduction of a bottle of sterile water with a shrink-wrapped plastic tamper-resistant seal into the isolator material transfer chamber.

“Inserting bottles with intact tamper seals into the chamber is specifically prohibited by your firm’s isolator,” they observed.

“If a water bottle is inserted into the chamber with an intact seal, only the exposed surfaces of the bottle would be rendered sterile. The part of the bottle covered by an intact tamper seal would not be sterilised.”

“Removal of the seal could compromise the sterility of the surrounding aseptic manufacturing environment,” they concluded.

The FDA also noted “... the online semi-automated visual inspection of vials ... is inadequate to ensure that potentially defective or otherwise unsuitable units are not reintroduced into the manufacturing process.”

Speaking to Bloomberg, Pfizer spokeswoman Rachel Hooper said the issues raised by the FDA do not impact products currently on the market that were manufactured at the Kansas site, “Patient safety is of primary importance to Pfizer,” she said. “The company is committed to ensuring the safety and quality of our medicines.”

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