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.
Source Documents
Direct, authoritative source material on this story.
Reference Articles
Articles Citable has ingested related to this story.
Media Coverage
Percentage of day’s news
Article Sentiment
Citable analysis assessing the language of each article related to the story as positive, negative or neutral.
Publications
Publications covering this story along with their cumulative positive or negative sentiment.