Overview
- 9 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-14.
At a glance
Inspections
9
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Nov 2025 – 14 Nov 2025 | Human Drugs | Clean | |
| 3 Jul 2023 – 11 Jul 2023 | Human Drugs | 483 | View 483 → |
| 6 Jan 2020 – 10 Jan 2020 | Human Drugs | 483 | View 483 → |
| 5 Aug 2019 – 8 Aug 2019 | Human Drugs | Clean | |
| 10 Sep 2018 – 12 Sep 2018 | Human Drugs | Clean | |
| 7 May 2018 – 11 May 2018 | Human Drugs | Clean | |
| 22 May 2017 – 26 May 2017 | Human Drugs | Clean | |
| 1 Aug 2016 – 5 Aug 2016 | Human Drugs | Clean | |
| 20 Mar 2015 – 27 Mar 2015 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Jul 2023
21 CFR 211.194(a)(1)
Sample identification and other information
Cited by Saundrea A Munroe, Raquel Gonzalez Rivera
10 Jan 2020
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Marcellinus D Dordunoo
Investigators
FDA investigators tied to this site in the record.
Robert M Barbosa2 insp.
Samir C Gala1 insp.
Saundrea A Munroe1 insp.
Raquel Gonzalez Rivera1 insp.
Marcellinus D Dordunoo1 insp.
Zachary L Stamm1 insp.
Helen Verdel1 insp.
Azza Talaat1 insp.
Michael A Taylor1 insp.
Guo Q Shen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lupin Limited's 2 Form 483s
Source PDFs 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