Pfizer’s newest vaccine plant has persistent mold issues, history of recalls
Pfizer's management knew last year there was "a mold issue" at the Kansas facility now slated to produce the drugmaker's urgently needed covid-19 vaccine, according to a Food and Drug Administration inspection report.
The McPherson, Kansas, facility, which FDA inspectors wrote is the nation's largest manufacturer of sterile injectable controlled substances, has a long, troubled history. Nearly a decade's worth of FDA inspection reports, recalls and reprimands reviewed by KHN show the facility as a repeat offender. FDA investigators have repeatedly noted in reports that the plant has failed to control quality and contamination or fully investigate after production failures.