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Not Kept "Clean and Sanitary"

An inspection by the US Food and Drug Administration has uncovered problems with maintaining sanitary conditions and preventing cross contamination at the Emergent BioSolutions plant where SARS-CoV-2 vaccines had to be destroyed, the Wall Street Journal reports.

Earlier this month, the New York Times reported that about 15 million doses of Johnson & Johnson's vaccine were ruined due to contamination with AstraZeneca's SARS-CoV-2 vaccine, which was also being manufactured at the plant. The Times further reported that the Emergent plant appeared to have a history of making errors.

According to the Journal, the FDA completed its inspection Tuesday and found that Emergent did not keep the plant "in a clean and sanitary condition." In particular, it noted cross contamination between materials used for different vaccines, workers not following proper procedures for wearing sterile gowns, and peeling paint. "There is no assurance that other batches have not been subject to cross contamination," the report says.

The Journal adds that the agency is working with Emergent to rectify the issues, and notes that production at the facility has been paused and that no material from it will be released without undergoing additional testing.

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