Overview
- 19 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-01-09.
At a glance
Inspections
19
Form 483s
4
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Jan 2026 – 9 Jan 2026 | Human Drugs | Clean | |
| 7 Feb 2022 – 18 Feb 2022 | Human Drugs | Clean | |
| 17 Jan 2019 – 24 Jan 2019 | Human Drugs | Clean | |
| 11 Dec 2017 – 14 Dec 2017 | Human Drugs | 483 | View 483 → |
| 18 Sep 2017 – 27 Sep 2017 | Human Drugs | 483 | On file |
| 14 Nov 2016 – 16 Nov 2016 | Human Drugs | Clean | |
| 4 Apr 2016 – 8 Apr 2016 | Human Drugs | Clean | |
| 29 Apr 2015 – 4 May 2015 | Human Drugs | 483 | View 483 → |
| 19 Sep 2014 – 29 Sep 2014 | Human Drugs | Clean | |
| 16 Oct 2013 – 22 Oct 2013 | Human Drugs | Clean | |
| 15 Nov 2012 | Not recorded | Clean | |
| 24 Mar 2010 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Helen Verdel3 insp.
Jose M Cayuela3 insp.
Emmanuel J Ramos2 insp.
Tanya R Syffrard1 insp.
Tomika L Crafter1 insp.
Robin P Mathew1 insp.
Junho Pak1 insp.
Tonia F Bernard1 insp.
Yvins Dezan1 insp.
Nancy F Scheraga1 insp.
Stephen J Mottola1 insp.
Paul L Bellamy1 insp.
Karen E Dorazio1 insp.
Barbara J Wilimczyk-Macri1 insp.
Douglas C Kovacs1 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 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ingenus Pharmaceuticals NJ, LLC.'s 4 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