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Emergent Biosolutions will address issues listed by FDA
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Emergent Biosolutions will address issues listed by FDA

FDA releases report on Emergent BioSolutions. Report lists severe flaws at vaccine plant.

Where: Baltimore, MD

The Facts

▪ The FDA released an inspection report Wednesday on the Emergent Biosolutions plant in Baltimore.

▪ Workers at Emergent Biosolutions destroyed a batch of vaccines containing up to 15 million doses due to a manufacturing error.

▪ The report commented that the plant was small, inadequately designed, and unclean.

▪ “The firm has failed to adequately train personnel involved in manufacturing operations, quality control sampling, weigh and dispense, and engineering operations to prevent cross-contamination of bulk drug substances,” the report said.

▪ Emergent Biosolutions issued a statement saying their company will resolve the issues listed in the report, in cooperation with FDA and J&J.

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