Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-17.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Jul 2025 – 17 Jul 2025 | Human Drugs | 483 | View 483 → |
| 8 Oct 2018 – 18 Oct 2018 | Human Drugs | 483 | View 483 → |
| 12 Jun 2017 – 16 Jun 2017 | Human Drugs | 483 | View 483 → |
| 5 Jun 2017 – 8 Jun 2017 | Human Drugs | Clean | |
| 23 Mar 2015 – 27 Mar 2015 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Jul 2025
21 CFR 211.110(a)
Written in-process control procedures
Cited by Lisa L Flores, Rafeeq A Habeeb
17 Jul 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Lisa L Flores, Rafeeq A Habeeb
17 Jul 2025
21 CFR 211.84(d)(2)
Testing Each Component for Conformity with Specs
Cited by Lisa L Flores, Rafeeq A Habeeb
18 Oct 2018
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Yasamin Ameri
18 Oct 2018
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Yasamin Ameri
Investigators
FDA investigators tied to this site in the record.
Lisa L Flores1 insp.
Rafeeq A Habeeb1 insp.
Yasamin Ameri1 insp.
Doan T Nguyen1 insp.
Zhigang Sun1 insp.
Hasan A Irier1 insp.
Young M Choi1 insp.
Uttaniti Limchumroon1 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 | 4x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(c)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lupin Limited's 3 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