FDA 483 - Emergent Biodefense Operations Lansing LLC

An FDA inspection of Bioport Corporation, a vaccine manufacturer in Lansing, Michigan, revealed significant quality system deficiencies. The firm failed to conduct complete investigations into manufacturing failures and deviations, maintain equipment properly, and ensure the timely implementation and tracking of corrective actions. Additionally, issues were noted with computer system qualification, visual inspection criteria, and the completeness and timeliness of Annual Product Reviews.