Lupin Limited Unit 1
FDA inspection history across 3 sites, 2009 to 2022
- 3
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2009: one warning letter; 2018: two Form 483s; 2019: one close-out letter; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2009One warning letter.
- 2018–19Two Form 483s and one close-out letter, at Madhya. Pradesh, India; Mandideep, India and Mumbai, India.
- 2018The longest 483 on file: 10 observations over 25 pages at Madhya. Pradesh, India.
- 2022One Form 483, at Mandideep, India.
Cited most
Across all Lupin Limited Unit 1 observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.192Production record review1
- 21 CFR 211.25Personnel qualifications1
The complete Lupin Limited Unit 1 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
Mandideep, India
Two Form 483s · 2018 to 2022 · 11 observations
Latest: Form 483, Nov 23, 2022 →Mumbai, India
One close-out letter · 2019
Latest: Close-out, Sep 10, 2019 →Madhya. Pradesh, India
One Form 483 · 2018 · 10 observations
Latest: Form 483, Dec 4, 2018 →
Also: one document not tied to a site.
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-11-23 | 483 Form 483 | Mandideep, India | 1 | $99 |
| 2019-09-10 | Close-out Close-out letter | Mumbai, India | — | $99 |
| 2018-12-04 | 483 Form 483 | Madhya. Pradesh, India | 10 | $99 |
| 2018-11-26 | 483 Form 483 | Mandideep, India | 10 | $99 |
| 2009-05-07 | Warning letter Warning letter | — | — | $99 |
Investigators on these documents
Christopher Keating (2)June P. Page (2)Pratik S. Upadhyay (2)Rajiv R. Srivastava (1)Thomas J. Arista (1)Unnee Ranjan (1)
FEI number 3002807511 · most recent document Nov 23, 2022
About Lupin Limited Unit 1
How many FDA Form 483s has Lupin Limited Unit 1 received?
FDA Intel has 3 Form 483s on file for Lupin Limited Unit 1; the most recent is dated Nov 23, 2022.
When was Lupin Limited Unit 1 last inspected by FDA?
The most recent FDA inspection document on file for Lupin Limited Unit 1 is a Form 483 dated Nov 23, 2022, for the site in Mandideep, India.
What did FDA cite at Lupin Limited Unit 1?
The regulations cited most in the observations on file for Lupin Limited Unit 1 are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.
Has Lupin Limited Unit 1 received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Lupin Limited Unit 1; the most recent is dated May 7, 2009.