Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar
FDA inspection history across 2 sites, 2019 to 2022
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2019: one Form 483; 2022: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Tarapur, India.
- 2022One warning letter and one Form 483, at Palghar, India and Tarapur, India.
- 2022The longest 483 on file: 4 observations over 8 pages at Tarapur, India.
Cited most
Across all Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.188Batch production and control records1
The complete Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar 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
Tarapur, India
Two Form 483s · 2019 to 2022 · 7 observations
Latest: Form 483, Apr 4, 2022 →Palghar, India
One warning letter · 2022
Latest: Warning letter, Sep 27, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-09-27 | Warning letter Warning letter | Palghar, India | — | $99 |
| 2022-04-04 | 483 Form 483 | Tarapur, India | 4 | $99 |
| 2019-09-20 | 483 Form 483 | Tarapur, India | 3 | $99 |
Investigators on these documents
FEI number 3002807512 · most recent document Sep 27, 2022
About Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar
How many FDA Form 483s has Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar received?
FDA Intel has 2 Form 483s on file for Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar; the most recent is dated Apr 4, 2022.
When was Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar last inspected by FDA?
The most recent FDA inspection document on file for Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar is a Form 483 dated Apr 4, 2022, for the site in Tarapur, India.
What did FDA cite at Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar?
The regulations cited most in the observations on file for Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.
Has Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar; the most recent is dated Sep 27, 2022.