Pfizer’s McPherson plant, filling COVID-19 vaccine, dinged for repeat offenses last January: report

h/t Jorge.

by Fraiser Kansteiner | Mar 5, 2021

Fierce Pharma:

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. more here