Lupin Limited
FDA inspection history in Nagpur, India, 2022 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Nagpur, India.
- 2025One Form 483, at Nagpur, India.
- 2025The longest 483 on file: 6 observations over 8 pages at Nagpur, India.
Cited most
Across all Lupin Limited observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.192Production record review2
- 21 CFR 211.166(a)(3)Stability testing1
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment1
The complete Lupin Limited file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Nagpur, India
Two Form 483s · 2022 to 2025 · 6 observations
Latest: Form 483, Sep 16, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-09-16 | 483 Form 483 | Nagpur, India | 6 | $99 |
| 2022-10-29 | 483 Form 483 | Nagpur, India | — | $99 |
Investigators on these documents
FEI number 3015392060 · most recent document Sep 16, 2025
About Lupin Limited
How many FDA Form 483s has Lupin Limited received?
FDA Intel has 2 Form 483s on file for Lupin Limited; the most recent is dated Sep 16, 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 Sep 16, 2025, for the site in Nagpur, India.
What did FDA cite at Lupin Limited?
The regulations cited most in the observations on file for Lupin Limited are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.192 (Production record review), 2 times.