FDA 483 - Serum Institute of India Pvt. Ltd. - January 30, 2026

An FDA inspection of Serum Institute of India Private Ltd. in Hadapsar, Pune, revealed significant deficiencies in their vaccine manufacturing operations. The firm failed to thoroughly investigate out-of-specification results for SARS-CoV-2rS drug substance and product, and exhibited poor documentation practices for production and process controls. Additionally, equipment and utensils were not adequately cleaned and maintained, raising concerns about product contamination.