Pfizer has tapped its McPherson, Kansas, manufacturing plant for fill-finish work as it hustles to double its weekly COVID-19 vaccine output in the U.S. But the facility has a history of problems—and found itself in the FDA's crosshairs as recently as last January.
Pfizer’s McPherson plant was dinged by FDA inspectors for quality and cleanliness issues during a visit in late 2019 and early 2020, according to an inspection report obtained by Bloomberg via the Freedom of Information Act.
The plant, enlisted to fill and finish doses of Pfizer and BioNTech’s COVID-19 vaccine Comirnaty, has received a laundry list of complaints from the FDA since Pfizer acquired it as part of its Hospira buyout in 2015. Pfizer has repeatedly vouched for remediation efforts there, and “as of today, the McPherson site’s plan remains on track, with nearly all of the improvements completed,” Eamonn Nolan, senior manager of global media relations at Pfizer, said via email.
The 2019-20 inspection found that the plant had released drugs without reviewing quality issues flagged during routine testing. Inspectors also turned up mold and bacteria in areas that were meant to be sterile and said the plant neglected to properly sample drugs for excessive levels of certain toxins, Bloomberg reported.
Specifically, the McPherson plant failed to adequately test for endotoxins—which are created by bacteria like Escherichia coli or botulism—in drugs such as morphine and the cancer med Nivestym.
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Meanwhile, an FDA visit in 2018 found Pfizer had identified mold at McPherson linked to product residue on machinery. The company said inadequate cleaning was to blame but discovered residue in the same area months later. As of the latest inspection, Pfizer “continues to recover bacterial and/or mold isolates from critical zones,” according to the FDA.
Following the inspection in January, "Pfizer immediately developed and implemented a robust corrective and preventive action plan to address the FDA’s observations," Nolan said. The company has made "significant" investments in resources, equipment and facilities at the McPherson site, which is currently operating in a "state of good manufacturing practice compliance," he said.
Pfizer feels confident its McPherson plant is up to the task and plans to complete all improvement actions tied to the COVID-19 manufacturing process before doses are supplied from the plant, Nolan added.
Pfizer last month revealed plans to more than double its vaccine output in the U.S. from around 4 million to 5 million doses per week to more than 13 million doses per week starting in mid-March. The production boost came courtesy of “significant” investments in Pfizer’s manufacturing sites in Missouri, Massachusetts and Wisconsin, plus the addition of new lines at the McPherson plant.
Pfizer is also tackling the final manufacturing step, where the vaccine is filled into vials and packaged for distribution, at its Kalamazoo, Michigan site.
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When Pfizer bought Hospira for $15 billion back in 2015, execs acknowledged the company’s history of regulatory problems. At the time, Pfizer said it believed Hospira had successfully wrangled its issues, but the FDA apparently didn’t agree, slapping Pfizer with a warning letter in 2017.
The letter dinged Pfizer’s McPherson plant for failing to fully investigate complaints of particulates found in vials of its products and noted that it had released one lot of an injected drug in which “brown agglomerates” were observed during production—among other issues. The FDA cited five other Hospira plants for similar problems in four warning letters sent out between 2010 and 2015.
An August 2018 visit found the McPherson plant was still not up to par. In a Form 483 from that time period, the FDA made eight observations, seven of them repeats, and some noted at least twice before.
In 2019, CEO Albert Bourla said Pfizer expected to get its sterile injectables on track by the end of the year. By April of 2020, Bourla reported that the company was able to stock 90% of its sterile injectables portfolio, thanks to remediation and modernized manufacturing investments.
Last March, the company distributed seven-and-a-half times the baseline demand of 30 of its sterile injectable products to cover back demand and shipped 10 drugs at more than double the demand, Bourla said. In some cases, it even delivered sterile injectables at more than five times demand, signaling a newfound ability to deploy its portfolio at scale.
Editor's note: This story has been updated with additional comments from Pfizer.