The FDA’s report gives the clearest picture yet of some of the manufacturing failings that led to the costly error at Emergent’s plant last month, a setback that could imperil the steady supply of J&J’s vaccine in the U.S.
Inspectors from the agency descended on the Baltimore facility, known as Bayview, on April 12, nearly two weeks after initial reports of the contamination and its immediate consequences. Over nine days at the site, and after reviewing security camera footage and building access logs, the officials made nine specific “observations,” or findings of concern.
