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

Source: https://www.keypedia.com/records/483/serum-institute-of-india-pvt-ltd/229041b2-34ce-4dd6-b7b7-2ede336926cf

> FDA 483 for Serum Institute of India Pvt. Ltd. on January 30, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Serum Institute of India Pvt. Ltd.
- Inspection Date: 2026-01-30
- Product Type: biologics
- Office Name: Office of Inspections and Investigations
- Summary: 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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Company: https://www.keypedia.com/companies/serum-institute-of-india-pvt-ltd/a1288932-02ec-49e6-942a-e8d90c93b890

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8