Jubilant Generics Limited
FDA inspection history across 3 sites, 2018 to 2024
- 4
- Form 483s
- 2
- Close-outs
Every document, by year
- Close-out
- Form 483
2018: one Form 483; 2019: one close-out letter; 2021: one Form 483; 2022: one Form 483; 2024: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–24Four Form 483s and two close-out letters, at Roorkee, India; Hardiwar, India and Sikanderpur Bhainswal, India.
- 2021The longest 483 on file: 7 observations over 16 pages at Hardiwar, India.
Cited most
Across all Jubilant Generics Limited observations on file
- 21 CFR 211.192Production record review6
- 21 CFR 211.110Sampling and testing of in-process materials and drug products3
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.160General requirements2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
The complete Jubilant Generics Limited file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Roorkee, India
Two Form 483s · 2018 to 2024 · 8 observations
Latest: Form 483, Feb 2, 2024 →Sikanderpur Bhainswal, India
One Form 483 · 2022 · 6 observations
Latest: Form 483, Aug 1, 2022 →Hardiwar, India
One Form 483 · 2021 · 7 observations
Latest: Form 483, Mar 12, 2021 →
Also: two documents not tied to a site.
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-04-23 | Close-out Close-out letter | — | — | $99 |
| 2024-02-02 | 483 Form 483 | Roorkee, India | 4 | $99 |
| 2022-08-01 | 483 Form 483 | Sikanderpur Bhainswal, India | 6 | $99 |
| 2021-03-12 | 483 Form 483 | Hardiwar, India | 7 | $99 |
| 2019-03-06 | Close-out Close-out letter | — | — | $99 |
| 2018-08-08 | 483 Form 483 | Roorkee, India | 4 | $99 |
Investigators on these documents
Dipesh K. Shah (1)Jeffrey P. Raimondi (1)Rajiv R. Srivastava (1)Rita K. Kabaso (1)Tamil Arasu (1)Unnee Ranjan (1)Yvins Dezan (1)
FEI number 3006895982 · most recent document Apr 23, 2024
About Jubilant Generics Limited
How many FDA Form 483s has Jubilant Generics Limited received?
FDA Intel has 4 Form 483s on file for Jubilant Generics Limited; the most recent is dated Feb 2, 2024.
When was Jubilant Generics Limited last inspected by FDA?
The most recent FDA inspection document on file for Jubilant Generics Limited is a Form 483 dated Feb 2, 2024, for the site in Roorkee, India.
What did FDA cite at Jubilant Generics Limited?
The regulations cited most in the observations on file for Jubilant Generics Limited are 21 CFR 211.192 (Production record review), 6 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 3 times; 21 CFR 211.22 (Responsibilities of quality control unit), 3 times.