FDA 483 - Emergent Biodefense Operations Lansing LLC - December 13, 2023

Emergent Biodefense Operations Lansing LLC was cited for significant manufacturing deficiencies during an FDA inspection. The firm has failed to identify the root cause of corroded copper particles found in its AV7909 finished drug product, despite numerous investigations and the release of affected lots. Additionally, production records at their Contract Manufacturing Organization lacked essential equipment identification for critical manufacturing steps.