FDA 483 - Emergent Biodefense Operations Lansing LLC - December 01, 2009

An FDA inspection of Emergent BioDefense Operations Lansing Inc. in Lansing, MI, a vaccine manufacturer, revealed significant deficiencies across multiple areas of its BioThrax® and Anthrax vaccine production. Key issues included inadequate handling of out-of-specification results, failures in aseptic processing, and a lack of proper documentation and procedures for critical manufacturing and quality control activities. The findings indicate a need for improved quality unit oversight, robust investigation processes, and adherence to sterile manufacturing protocols.