Report Finds History of Quality Control Failures at Maryland Biotech Company

The Maryland biotech company that was forced to dump 15 million doses of COVID-19 vaccine due to contamination last week has a history of failing quality control audits despite the government contract it provided to the installation $ 163 million, according to a report from The New York Times.

The Times story, which is based on documents and interviews with current and former federal officials, as well as former employees of Emergent Biosolutions, which operated a plant in Baltimore to produce the vaccines, found several problems.

He blamed a corporate culture that “ignored or deflected missteps” and said the government – specifically the Advanced Biomedical Research and Development Authority – did little to control it.

Documents reviewed by the Times showed that an AstraZeneca audit of the facility found a high risk of cross contamination at the plant.

The plant ended up producing both the AstraZeneca COVID-19 vaccine and a separate Johnson & Johnson vaccine. Fifteen million doses of Johnson & Johnson vaccines were thrown last week due to cross contamination with the AstraZeneca vaccine.

Other problems found during facility audits included mold contamination, improper equipment cleaning, insufficient employee training and raw materials not being tested, according to the Times.

“Do you want me to manufacture drugs or solve problems? I don’t have time to do both, ”said a senior manufacturing supervisor when quality issues arose, according to The New York Times.

The Hill has contacted Emergent Biosolutions for comment.

“Any allegation that our safety, quality and compliance systems are not working or that we do not take these responsibilities seriously is false,” Emergent spokesman Matt Hartwig told the outlet.

There are another 62 million Johnson & Johnson vaccines trapped in the facility as officials determine if they were also contaminated.

The Federal Drug Administration has not authorized the facility to distribute vaccine doses, so the plant has not produced a dose that has been used on the market.

Johnson & Johnson is taking over supervision of the facility, while Biden’s management is helping AstraZeneca find a new manufacturing partner.


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