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Report finds history of quality control lapses at Maryland biotech firm

Report finds history of quality control lapses at Maryland biotech firm
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The Maryland biotech firm that was forced to toss 15 million COVID-19 vaccine doses due to contamination last week has a history of failing to pass quality control audits despite the government contract that provided the facility with $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 was operating a plant in Baltimore to produce the vaccines, found a number of problems. 

It faulted a corporate culture that "ignored or deflected missteps" and said the government — specifically the Biomedical Advanced Research and Development Authority — did little to police it.

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

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

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

“Do you want me to make drugs or fix issues? I don’t have time to do both,” a senior manufacturing supervisor would say when quality concerns arose, according to The New York Times.

The Hill has reached out to 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.

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There are another 62 million Johnson & Johnson vaccines stuck at the facility as officials determine if they were contaminated as well.

The Federal Drug Administration has not cleared the facility to distribute vaccine doses, so the plant has not made one dose that has been used on the market.

Johnson & Johnson is taking control of the oversight of the facility while the Biden administration is helping AstraZeneca find a new manufacturing partner.