
FDA Unveils Extensive Manufacturing Violations at Emergent
A FDA report cites multiple ongoing violations that undermine assurance of quality in products from this plant and the need for a continuing “pause” in production.
Just in case anyone suspected FDA of over-reacting to problems at this troubled vaccine production site—or that any poor-quality materials could be released—FDA officials have taken the unusual step of issuing the closeout report (Form 483) on its just-completed re-inspection of Emergent BioSolutions’ Baltimore manufacturing facility. The report cites multiple ongoing violations that undermine assurance of quality in products from this plant and the need for a continuing “pause” in production.
FDA Acting Commissioner Janet Woodcock and Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), issued a
FDA inspectors found
The situation now has drawn attention on Capitol Hill. Leaders of the House Oversight & Reform Committee and its Select Subcommittee on the Coronavirus Crisis have
Woodcock and Marks emphasize that they are “doing everything we can” to ensure that COVID-19 vaccines for Americans meet FDA’s high standards for quality, safety, and effectiveness. The result, they hope, is that FDA will maintain the public’s trust in its operations.
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.