Lupin Limited 15-B, Phase 1A, Verna Industrial Area
FDA inspection history across 3 sites, 2011 to 2021
- 5
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2011: one Form 483; 2015: one Form 483; 2017: one warning letter and one Form 483; 2019: one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One Form 483, at Verna, Salcette, Goa, India.
- 2011The longest 483 on file: 7 observations over 19 pages at Verna, Salcette, Goa, India.
- 2015–21Four Form 483s and one warning letter, at Verna, India and Mumbai, India.
Cited most
Across all Lupin Limited 15-B, Phase 1A, Verna Industrial Area observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.160General requirements2
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.100Written procedures; deviations1
The complete Lupin Limited 15-B, Phase 1A, Verna Industrial Area 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
Verna, India
Four Form 483s · 2015 to 2021 · 11 observations
Latest: Form 483, Sep 18, 2021 →Mumbai, India
One warning letter · 2017
Latest: Warning letter, Nov 6, 2017 →Verna, Salcette, Goa, India
One Form 483 · 2011 · 7 observations
Latest: Form 483, Nov 10, 2011 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-09-18 | 483 Form 483 | Verna, India | 7 | $99 |
| 2019-02-08 | 483 Form 483 | Verna, India | 2 | $99 |
| 2017-11-06 | Warning letter Warning letter | Mumbai, India | — | $99 |
| 2017-04-07 | 483 Form 483 | Verna, India | 1 | $99 |
| 2015-07-17 | 483 Form 483 | Verna, India | 1 | $99 |
| 2011-11-10 | 483 Form 483 | Verna, Salcette, Goa, India | 7 | $99 |
Investigators on these documents
Andrew J. Idzior (1)Charanjeet S. Jassal (1)Jogy George (1)Lata Mathew (1)Luis A. Dasta (1)Pratik S. Upadhyay (1)Tamil Arasu (1)Unnee Ranjan (1)
FEI number 3004819820 · most recent document Sep 18, 2021
About Lupin Limited 15-B, Phase 1A, Verna Industrial Area
How many FDA Form 483s has Lupin Limited 15-B, Phase 1A, Verna Industrial Area received?
FDA Intel has 5 Form 483s on file for Lupin Limited 15-B, Phase 1A, Verna Industrial Area; the most recent is dated Sep 18, 2021.
When was Lupin Limited 15-B, Phase 1A, Verna Industrial Area last inspected by FDA?
The most recent FDA inspection document on file for Lupin Limited 15-B, Phase 1A, Verna Industrial Area is a Form 483 dated Sep 18, 2021, for the site in Verna, India.
What did FDA cite at Lupin Limited 15-B, Phase 1A, Verna Industrial Area?
The regulations cited most in the observations on file for Lupin Limited 15-B, Phase 1A, Verna Industrial Area are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.22 (Responsibilities of quality control unit), 3 times; 21 CFR 211.160 (General requirements), 2 times.
Has Lupin Limited 15-B, Phase 1A, Verna Industrial Area received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Lupin Limited 15-B, Phase 1A, Verna Industrial Area; the most recent is dated Nov 6, 2017.