FDA inspection of Emergent’s Baltimore site in 2020 raises new questions
The FDA on Thursday raised fresh quality concerns about Emergent BioSolutions’ manufacturing site in Baltimore, which has more recently been taken over by J&J after an error caused the site to discard about 15 million doses of the company’s vaccine last month.
According to a Form 483 issued to the contract testing lab last April, following a 7-day inspection and just released by the FDA, Emergent’s quality unit failed to ensure some very basic, fundamental activities, like that staff couldn’t just delete or manipulate electronic data, and the responsibilities and procedures for the quality unit were not in writing or fully followed, FDA said.
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