Lupin Limited (Unit II)
FDA inspection history across 2 sites, 2016 to 2018
- 2
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–18Two Form 483s, at Madhya Pradesh, India and Mandideep, India.
- 2016The longest 483 on file: 4 observations over 4 pages at Madhya Pradesh, India.
Cited most
Across all Lupin Limited (Unit II) observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.198Complaint files1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Lupin Limited (Unit II) 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
Mandideep, India
One Form 483 · 2018
Latest: Form 483, Dec 4, 2018 →Madhya Pradesh, India
One Form 483 · 2016 · 4 observations
Latest: Form 483, Aug 12, 2016 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-12-04 | 483 Form 483 | Mandideep, India | — | $99 |
| 2016-08-12 | 483 Form 483 | Madhya Pradesh, India | 4 | $99 |
Investigators on these documents
FEI number 3007756473 · most recent document Dec 4, 2018
About Lupin Limited (Unit II)
How many FDA Form 483s has Lupin Limited (Unit II) received?
FDA Intel has 2 Form 483s on file for Lupin Limited (Unit II); the most recent is dated Dec 4, 2018.
When was Lupin Limited (Unit II) last inspected by FDA?
The most recent FDA inspection document on file for Lupin Limited (Unit II) is a Form 483 dated Dec 4, 2018, for the site in Mandideep, India.
What did FDA cite at Lupin Limited (Unit II)?
The regulations cited most in the observations on file for Lupin Limited (Unit II) are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.