Pfizer COVID-19 Vaccine Manufacturing Plant Had Recurring Problems

A Pfizer plant that will produce the company’s COVID-19 vaccine has been observed by FDA investigators as having quality control lapses, but Pfizer says the problems will be resolved before the facility supplies any COVID-19 vaccine doses.

During an inspection at the end of 2019 and January 2020, agency officials reportedly found that Pfizer’s McPherson, Kansas, plant was releasing products to market without fully addressing quality concerns raised during testing.

In addition, the FDA investigators found microcontaminants in sterile areas ― an issue which the agency had noted in a previous inspection ― and found that drug products weren’t adequately sampled to make sure they didn’t contain certain toxins.

The plant had been on the FDA’s risk-based inspection radar for several years. In March 2017, the agency issued a warning letter regarding the McPherson plant (DID, March 14, 2017). And in June 2018, the agency determined that Pfizer had corrected the outstanding problems, but it returned to the facility a month later and found more issues.

“Following the January 2020 inspection, Pfizer immediately developed and implemented a robust corrective and preventive action plan to address the FDA’s observations at our McPherson site,” Pfizer told FDAnews. “The McPherson site’s plan remains on track, with nearly all of the improvements completed.”

Pfizer says it has made significant investments in resources, equipment and facilities at the site, and that it is “now operating in a good state of good manufacturing practice compliance. We will complete all improvement actions related to the COVID-19 manufacturing area before COVID-19 doses are supplied from the facility.”

The plant is reportedly authorized to produce remdesivir for Gilead Sciences. ― Jason Scott