Overview
- 11 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-21.
At a glance
Inspections
11
Form 483s
8
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Nov 2025 – 21 Nov 2025 | Human Drugs | 483 | On file |
| 6 Sep 2021 – 18 Sep 2021 | Human Drugs | 483 | On file |
| 28 Jan 2019 – 8 Feb 2019 | Human Drugs | 483 | On file |
| 17 Jul 2017 – 21 Jul 2017 | Human Drugs | Clean | |
| 27 Mar 2017 – 7 Apr 2017 | Human Drugs | 483 | On file |
| 7 Mar 2016 – 11 Mar 2016 | Human Drugs | 483 | View 483 → |
| 9 Jul 2015 – 17 Jul 2015 | Human Drugs | 483 | View 483 → |
| 13 May 2013 – 17 May 2013 | Human Drugs | Clean | |
| 16 Sep 2011 | Not recorded | Clean | |
| 12 Feb 2010 | Not recorded | 483 | On file |
| 4 Mar 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Mar 2016
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Erika V Butler, Jason K Morgan
11 Mar 2016
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Erika V Butler, Jason K Morgan
11 Mar 2016
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Erika V Butler, Jason K Morgan
11 Mar 2016
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Erika V Butler, Jason K Morgan
Investigators
FDA investigators tied to this site in the record.
Tamil Arasu1 insp.
Pratik S Upadhyay1 insp.
Rajiv R Srivastava1 insp.
Nancy M Espinal1 insp.
Lata C Mathew1 insp.
Unnee Ranjan1 insp.
Xikui Chen1 insp.
Melkamu Getie Kebtie1 insp.
Jogy George1 insp.
Andrew J Idzior1 insp.
Erika V Butler1 insp.
Jason K Morgan1 insp.
Charanjeet Jassal1 insp.
Luis A Dasta1 insp.
Azza Talaat1 insp.
Patric C Klotzbuecher1 insp.
Mural B Gavini1 insp.
Katherine Szestypalow1 insp.
Kevin P Foley1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.50 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Lupin Limited's 8 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat