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