FDA 483 - Emergent Biodefense Operations Lansing LLC - September 29, 2021

An FDA inspection of Emergent BioDefense Operations Lansing LLC in Lansing, MI, revealed that the firm's reserve drug product samples were not representative of each lot or batch. This issue stemmed from an inadequate sample collection plan and a deficient standard operating procedure (SOP) for retention sampling. The firm failed to collect samples throughout the entire production lot for products like BioThrax® and AV7909.