# FDA 483 - Jubilant Generics Limited - February 02, 2024

Source: https://www.keypedia.com/records/483/jubilant-generics-limited/cd07e558-a1b5-46b3-8c1c-fd4afe0b5937

> FDA 483 for Jubilant Generics Limited on February 02, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jubilant Generics Limited
- Inspection Date: 2024-02-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Jubilant Generics Limited in Roorkee, India, was cited for significant deficiencies in its quality control and manufacturing processes during an FDA inspection. Observations included inadequate investigations into cleaning verification failures, poor documentation practices, and insufficient validation studies for critical process parameters. These issues indicate a lack of robust quality oversight and control over drug product manufacturing.

## Related Documents

- [483 - 2018-08-08](https://www.keypedia.com/records/483/jubilant-generics-limited/b9896784-4fab-4e77-ab8d-aae51c611789)
- [483 - 2021-03-12](https://www.keypedia.com/records/483/jubilant-generics-limited/9219a412-4212-46d1-a2bb-940877604df2)
- [483 - 2021-03-12](https://www.keypedia.com/records/483/jubilant-generics-limited/67003c16-ec1c-4768-8d71-d52ed40b5c21)
- [WARNING_LETTER - 2018-08-08](https://www.keypedia.com/records/warning_letter/jubilant-generics-limited/78b01487-1252-4946-a390-b1bd324069c9)
- [483 - 2025-08-01](https://www.keypedia.com/records/483/jubilant-generics-limited/39249dd0-cade-4536-8307-9474ecebe85d)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.keypedia.com/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

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