Overview
- 10 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-05.
At a glance
Inspections
10
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Sep 2025 – 5 Sep 2025 | Human Drugs | 483 | View 483 → |
| 6 Mar 2024 – 15 Mar 2024 | Human Drugs | 483 | On file |
| 10 Feb 2020 – 14 Feb 2020 | Human Drugs | Clean | |
| 6 May 2019 – 15 May 2019 | Human Drugs | 483 | View 483 → |
| 24 Jul 2017 – 28 Jul 2017 | Human Drugs | 483 | On file |
| 17 Apr 2017 – 26 Apr 2017 | Human Drugs | 483 | On file |
| 11 Jan 2016 – 15 Jan 2016 | Human Drugs | 483 | View 483 → |
| 30 Mar 2015 – 3 Apr 2015 | Human Drugs | 483 | View 483 → |
| 27 Jul 2012 | Not recorded | Clean | |
| 5 Nov 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 May 2019
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Rumany C Penn
Investigators
FDA investigators tied to this site in the record.
Christopher R Czajka1 insp.
Lisa L Flores1 insp.
Vaishali J Patel1 insp.
Matthew B Casale1 insp.
Rumany C Penn1 insp.
Michael L Casner1 insp.
Parul M Patel1 insp.
Doan T Nguyen1 insp.
Toyin B Oladimeji1 insp.
Meisha R Sampson1 insp.
Andrew J Idzior1 insp.
Meisha R Waters1 insp.
Kham Phommachanh1 insp.
Farhana Khan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lupin Ltd.'s 7 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