Overview
- 21 FDA inspections are on record.
- 15 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-09.
At a glance
Inspections
21
Form 483s
15
EIRs
5
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Feb 2026 – 9 Feb 2026 | Human Drugs | 483 | View 483 → |
| 16 Oct 2023 – 25 Oct 2023 | Human Drugs | Clean | |
| 2 Dec 2019 – 6 Dec 2019 | Human Drugs | 483 | View 483 → |
| 9 May 2018 – 25 May 2018 | Human Drugs | 483 | View 483 → |
| 20 Mar 2017 – 30 Mar 2017 | Human Drugs | 483 | On file |
| 13 Apr 2016 – 20 Apr 2016 | Human Drugs | Clean | |
| 13 May 2015 – 26 May 2015 | Human Drugs | 483 | View 483 → |
| 23 Feb 2015 – 13 Mar 2015 | Human Drugs | 483 | View 483 → |
| 26 Feb 2013 – 8 Mar 2013 | Human Drugs | 483 | View 483 → |
| 14 Jun 2012 | Not recorded | 483 | View 483 → |
| 2 Mar 2012 | Not recorded | 483 | View 483 → |
| 6 Jan 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Dec 2019
21 CFR 211.110(a)
Written in-process control procedures
Cited by Jose O Hernandez, Ganesh N Joshi
6 Dec 2019
21 CFR 211.165(a)
Testing and release for distribution
Cited by Jose O Hernandez, Ganesh N Joshi
6 Dec 2019
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Jose O Hernandez, Ganesh N Joshi
Investigators
FDA investigators tied to this site in the record.
Alice S Tsao4 insp.
Robert C Horan3 insp.
Robert C Steyert3 insp.
Sony Mathews2 insp.
Kevin A Gonzalez2 insp.
Vivin George1 insp.
Karishma G Gopaul1 insp.
Adena S Yau1 insp.
Jose O Hernandez1 insp.
Ganesh N Joshi1 insp.
Bijoy Panicker1 insp.
Dipesh K Shah1 insp.
Mindy M Chou1 insp.
Neil J Bonzagni1 insp.
Karl Auguste1 insp.
Charisse K Green1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | 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 |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.115(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(f)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind InvaGen Pharmaceuticals, Inc.'s 15 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