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Home » Emergent BioSolutions’ Bayview Site Gets Form 483 Following FDA Inspection
Emergent BioSolutions’ Bayview Site Gets Form 483 Following FDA Inspection
FDA investigators observed multiple problems at Emergent BioSolutions’ beleaguered Bayview facility in an April 12 to April 20 inspection prompted by a manufacturing mix-up for Johnson & Johnson (J&J)’s and AstraZeneca (AZ)’s COVID-19 vaccines, making it unlikely that the plant will be authorized to produce J&J doses anytime soon.