FDA Warning Letter Brings Another High-Flying Emergent CDMO Plant Down To Earth
Warning letter reveals agency found quality problems at Emergent BioSolutions’ Camden fill/finish plant during COVID-19 pandemic even as firm’s Bayview plant came under heightened scrutiny. Metal particulates appeared in vials as Camden plant and rest of Emergent’s CDMO network experienced sharp demand growth.
You may also be interested in...
BARDA terminates CIADM contract in wake of vaccine cross-contamination incident, begins discussion with industry about next steps for rapid pandemic response capabilities.
Responses to US FDA draft guidance suggest more promptness while also more elaborate processes for agency decision making based on remote methods. Questions include what’s voluntary, what’s mandatory, what can be decided remotely, and how to remotely move on from warning letters.
Memo outlines how US agency ensured sufficient delivery of updated COVID-19 vaccine doses even as it navigated unresolved inspection findings of the Catalent plant where the additional doses had been manufactured.