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

An FDA inspection of Emergent Bio-Defense, Inc. in Lansing, MI, revealed significant deficiencies in their anthrax vaccine manufacturing processes. Key issues included inadequate and untimely investigations into deviations and contaminations, incomplete documentation for manufacturing processes, and a lack of validation data for critical steps like sterile filtration and media preparation. The firm also demonstrated poor control over labeling, warehouse identification, water systems, and complaint handling, indicating a broad pattern of non-compliance with GMP regulations.