Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II
FDA inspection history in Pithampur, India, 2017 to 2025
- 3
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2018: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–18Two Form 483s, at Pithampur, India.
- 2018The longest 483 on file: 5 observations over 6 pages at Pithampur, India.
- 2025One Form 483, at Pithampur, India.
Cited most
Across all Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II observations on file
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.192Production record review2
- 21 CFR 211.67Equipment cleaning and maintenance1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II file.
All 3 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
Pithampur, India
Three Form 483s · 2017 to 2025 · 9 observations
Latest: Form 483, Jul 17, 2025 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-07-17 | 483 Form 483 | Pithampur, India | 3 | $99 |
| 2018-10-18 | 483 Form 483 | Pithampur, India | 5 | $99 |
| 2017-06-16 | 483 Form 483 | Pithampur, India | 1 | $99 |
Investigators on these documents
Doan T. Nguyen (1)Lisa L. Flores (1)Rafeeq Habeeb (1)Yasamin Ameri (1)Zhigang Sun (1)
FEI number 3009107538 · most recent document Jul 17, 2025
About Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II
How many FDA Form 483s has Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II received?
FDA Intel has 3 Form 483s on file for Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II; the most recent is dated Jul 17, 2025.
When was Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II last inspected by FDA?
The most recent FDA inspection document on file for Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II is a Form 483 dated Jul 17, 2025, for the site in Pithampur, India.
What did FDA cite at Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II?
The regulations cited most in the observations on file for Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II are 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 3 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 2 times; 21 CFR 211.192 (Production record review), 2 times.