# FDA 483 - Jubilant Generics Limited - August 01, 2025

Source: https://www.keypedia.com/records/483/jubilant-generics-limited/2fd780f0-354a-4b31-8a0a-a114b0a66789

> FDA 483 for Jubilant Generics Limited on August 01, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jubilant Generics Limited
- Inspection Date: 2025-08-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Jubilant Generics Limited in Roorkee, India, revealed significant deficiencies in equipment design, cleaning, data integrity, and process control. The firm failed to demonstrate that production equipment was suitable for its intended use and free from contamination, and lacked appropriate controls over computerized systems. Additionally, hold time studies were found to be deficient, using unrepresentative product quantities.

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## Related Officers

- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)
- [Md Abdullah A. Mahmud](https://www.keypedia.com/people/md-abdullah-a-mahmud/48c2d955-26fb-427b-9cca-0278bb37e6f7)

Company: https://www.keypedia.com/companies/jubilant-generics-limited/0e33a821-8bc0-4f36-9264-5a108f087380

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1