FDA 483 - Emergent Biodefense Operations Lansing LLC

An FDA inspection of Emergent BioDefense Operations Lansing, LLC's vaccine manufacturing facility revealed significant deficiencies across multiple quality systems. The firm failed to adequately document deviations, qualify raw materials, support expiration dates, control environmental contamination by Bacillus anthracis, and ensure effective cleaning validation. These issues indicate a broad lack of control over manufacturing processes, documentation, and investigations for products like BioThrax and Anthrax Vaccine Absorbed.