Serum Institute of India Pvt. Ltd. – FDA 483, Feb 2, 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 support cleaning processes and validation studies, and a failure to thoroughly investigate critical defects and implement effective corrective actions. These issues indicate a lack of robust quality systems necessary for vaccine production.