EMERGENT BIO-DEFENSE, INC. – FDA 483, Mar 11, 2008

The FDA inspection of Emergent Bio-Defense, Inc. in Lansing, MI, revealed significant deficiencies across its anthrax vaccine manufacturing operations. Issues included inadequate investigations into deviations and product contamination, insufficient documentation for manufacturing processes and quality control, and a lack of validation data for critical steps like sterile filtration and media storage. These findings indicate a systemic failure in maintaining robust quality systems and ensuring product quality and safety.