Lupin Limited
FDA inspection history across 2 sites, 2017 to 2025
- 5
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2019: one Form 483; 2023: one Form 483; 2025: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Two Form 483s, at Indore, India and Pithampur, India.
- 2023–25Three Form 483s, at Pithampur, India.
- 2023The longest 483 on file: 10 observations over 13 pages at Pithampur, India.
Cited most
Across all Lupin Limited observations on file
- 21 CFR 211.192Production record review6
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.160General requirements3
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products2
- 21 CFR 211.198Complaint files2
The complete Lupin Limited file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Pithampur, India
Four Form 483s · 2019 to 2025 · 24 observations
Latest: Form 483, Jul 17, 2025 →Indore, India
One Form 483 · 2017 · 1 observation
Latest: Form 483, May 19, 2017 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-07-17 | 483 Form 483 | Pithampur, India | 4 | $99 |
| 2025-07-08 | 483 Form 483 | Pithampur, India | 4 | $99 |
| 2023-03-29 | 483 Form 483 | Pithampur, India | 10 | $99 |
| 2019-01-25 | 483 Form 483 | Pithampur, India | 6 | $99 |
| 2017-05-19 | 483 Form 483 | Indore, India | 1 | $99 |
Investigators on these documents
Lisa L. Flores (2)Rafeeq Habeeb (2)Yvins Dezan (2)Darren S. Brown (1)Tamil Arasu (1)Eileen A. Liu (1)Jogy George (1)
FEI number 3007549629 · most recent document Jul 17, 2025
About Lupin Limited
How many FDA Form 483s has Lupin Limited received?
FDA Intel has 5 Form 483s on file for Lupin Limited; the most recent is dated Jul 17, 2025.
When was Lupin Limited last inspected by FDA?
The most recent FDA inspection document on file for Lupin Limited is a Form 483 dated Jul 17, 2025, for the site in Pithampur, India.
What did FDA cite at Lupin Limited?
The regulations cited most in the observations on file for Lupin Limited are 21 CFR 211.192 (Production record review), 6 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.160 (General requirements), 3 times.