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

An FDA inspection of Serum Institute of India Pvt. Limited Manjari Site in Pune, India, revealed significant deficiencies in vaccine manufacturing processes. Observations included inadequate requalification of equipment for COVID vaccine filling, insufficient data to support cleaning processes between different vaccine products, and an incomplete validation study. The firm also lacked data in qualification reports for reference standards and failed to fully investigate critical defects.