FDA 483 - Emergent Biodefense Operations Lansing LLC - April 12, 2016

An FDA inspection of Emergent BioDefense Operations Lansing LLC, a licensed biological manufacturer in Lansing, Michigan, revealed several deficiencies in their manufacturing and quality control processes for Anthrax Vaccine Adsorbed. Observations included inadequate investigations into mold contamination and out-of-specification potency results, lack of established reject limits and reinspection criteria for visual inspection, and insufficient environmental monitoring. The findings indicate a need for improved controls and adherence to established procedures to ensure product quality and safety.