FDA 483 - Serum Institute of India Pvt. Ltd. - July 02, 2024

An FDA inspection of Serum Institute of India Pvt. Limited Manjari Site, a vaccine manufacturer in Pune, India, revealed significant deficiencies in quality control and manufacturing processes. Observations included inadequate requalification of equipment for COVID vaccine filling, insufficient data to prevent cross-contamination between vaccine products, and uncompleted validation studies for critical processes. The firm also lacked qualification data for reference standards and failed to fully investigate critical defects, indicating systemic quality control problems.