Emergent Biosolutions will address issues listed by FDA
April 22, 2021
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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