The McPherson, Kan., facility slated to be used as a fill-and-finish site for Pfizer COVID-19 vaccines has a history of violations stemming from manufacturing quality concerns discovered during FDA inspections, Kaiser Health News reported March 10.
Kaiser Health News obtained several FDA reports from inspections conducted at the site in the last decade, finding that at least four scrupulous FDA inspections have been conducted at the site since Pfizer took over its operations in 2015, when it acquired Hospira.
In the reports, FDA inspectors noted that the facility is the country's largest manufacturer of sterile injectable controlled substances. They also wrote that the plant has repeatedly failed to implement effective quality and contamination controls or launch full internal investigations after manufacturing failures.
The site's record of recalls and field alerts show it produced medicine vials containing glass and cardboard particles. The site's January 2020 inspection report listed various observations that quality control measures were not being fully followed and surfaces were contaminated with mold and bacteria due to humidity and cleaning practices.
Pfizer spokesperson Eamonn Nolan told Kaiser Health News the drugmaker immediately developed a corrective plan to address the safety concerns from the site's January 2020 FDA investigation. Neither Pfizer nor the FDA responded to Kaiser Health News' requests for a copy of the plan.
Mr. Nolan also said Pfizer is planning ways to improve the facility's resources and equipment, and these improvements will be completed before COVID-19 vaccine production begins. He did not disclose when COVID-19 vaccine production will begin, but said the site is currently meeting the regulatory standards enforced by the FDA.
Several former FDA employees and industry experts told Kaiser Health News the ongoing investigational challenges with the facility illustrate how the agency must balance pursuing manufacturing compliance with the country's need to maintain a consistent medication supply.
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