BALTIMORE — Emergent BioSolutions, the Baltimore-based company manufacturing the Johnson & Johnson coronavirus vaccines, was asked to pause manufacturing COVID-19 related products by the FDA.
On April 12, the FDA initiated an inspection of Emergent’s Bayview facility. On April 16, at the request of the FDA, Emergent agreed not to initiate the manufacturing of any new material at the facility and to quarantine existing material manufactured there pending completion of the inspection and remediation of any resulting findings.
In a statement, Emergent BioSolutions said in part:
"This inspection is ongoing. While we await the FDA’s full feedback, we are working with J&J and the FDA on strengthening the supply chain for this vitally important vaccine.
We recognize the confusion these recent events may have caused our customers, our employees, and the public. We are steadfastly committed to full compliance with the FDA’s strict requirements. We acknowledge that there are improvements we must make to meet the high standards we have set for ourselves and to restore confidence in our quality systems and manufacturing processes."
It was allegedly human error that ruined 15 million doses of the Johnson & Johnson vaccine in late March. A New York Times article initially reported the issues.