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

Source: https://www.keypedia.com/records/483/jubilant-generics-limited/39249dd0-cade-4536-8307-9474ecebe85d

> 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 Inspections and Investigations
- Summary: Jubilant Generics Limited, a drug manufacturer in Roorkee, India, received a Form 483 with four observations during an FDA inspection. The firm was cited for issues including equipment not being of appropriate design, inadequate cleaning and maintenance of production equipment leading to contamination, and insufficient controls over computerized systems. Additionally, hold time studies were found deficient as product quantities used were not representative of actual batch sizes, with two observations being repeats from previous inspections.

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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-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8