FDA 483 - Emergent Biodefense Operations Lansing LLC

The inspection of Emergent BioDefense Operations, LLC in Lansing, Michigan, revealed significant deficiencies in the firm's quality control unit. The observations primarily concern inadequate oversight of contract fillers, lack of proper review for potential quality problems, insufficient quarantine procedures, undefined change control effectiveness checks, and incomplete impact assessments. These issues indicate a systemic failure in ensuring product quality and compliance with cGMP regulations.