FDA lays the hammer on Emergent's Baltimore plant after J&J debacle, halting all production in unusual move
Emergent BioSolutions has had a tough month: First, the CDMO ruined 15 million doses of J&J’s Covid-19 vaccine in March and then suffered the ignominy of the FDA seizing the reins. Now, as the agency receives a full accounting of the site’s problems, Emergent has slammed the brakes on all production at the FDA’s behest.
Emergent will cease manufacturing at its Baltimore plant until the FDA’s inspection and remediation of any findings is complete, the company said in a statement. Emergent will also quarantine existing materials that have already been manufactured. That stoppage started on Friday, four days after the initiation of the FDA’s inspection.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 112,900+ biopharma pros reading Endpoints daily — and it's free.