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# Pfizer Vaccine Plant Has Troubled Compliance History: Report
- URL: https://www.fdaweb.com/pfizer-vaccine-plant-has-troubled-compliance-history-report/
- Published: 2021-03-10T12:00:00.000Z
- Updated: 2026-09-14T16:50:18.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, #legacy-id-D5148847

A Pfizer facility in McPherson, KS, that is slated to start producing the company’s Covid-19 vaccine has a long history of mold and other contamination issues, according to inspection reports obtained by Kaiser Health News (KHN). The news service [says](https://khn.org/news/article/pfizer-new-vaccine-plant-persistent-mold-issues-history-of-recalls/?ref=fdaweb.com) “FDA investigators have repeatedly noted in reports that the plant has failed to control quality and contamination or fully investigate after production failures.”

Pfizer took over operations at McPherson in late 2015 after acquiring Hospira. KHN says FDA investigators appeared to be increasingly frustrated with the same issues cropping up at the facility that is said to be the nation’s largest manufacturer of sterile injectable controlled substances.

The company says that following a 1/2020 agency inspection it immediately developed and put in place a corrective action plan. **Eammon Nolan**, a company spokesman, declined to provide a copy of the plan to KHN and would not provide details on when manufacturing of the Covid-19 vaccine is set to start. “We are confident in the McPherson site’s ability to manufacture high-quality Covid-19 vaccine,” Nolan told the news service.

The article says it is unclear whether FDA investigators have returned to check on production practices at McPherson or will do so before vaccine production begins. FDA spokesperson **Abigail Capobianco** told the service that the public “can be assured that the agency used all available tools and information to assess compliance.”

KHN says the Pfizer emergency use authorization for the vaccine includes safeguards such as quarterly reports to FDA and a quality analysis from the company for each manufactured drug lot at least 48 hours before it is distributed.

The facility produces a wide array of sterile, generic medications used in hospitals, and its issues have led to some health system shortages, especially for injectable opioid analgesics, according to a 2018 FDA statement.

KHN says FDA rejected Pfizer’s biosimilar for Amgen’s anemia drug Epogen due to concerns about the McPherson fill/finish plant in 2017\. An agency 2017 Warning Letter said that contaminants such as cardboard and glass that were found in vials posed “a severe risk of harm to patients” and said the firm’s process for manufacturing sterile injectable products was “out of control.”

Kaiser says it appears the plant had been operating with an FDA rating of OAI (official action indicated) until the 1/2020 inspection, after which it was upgraded to VAI (voluntary action indicated), meaning that the agency trusted the company to address inspection observations. The article says the 2020 inspection report that led to the VAI rating listed repeat observations that involved quality control procedures not being fully followed and “contamination” with mold and bacteria on surfaces due to humidity and cleaning practices.