Drug factory · FDA FEI 2246963
Ingenus Pharmaceuticals NJ, LLC
140 NEW DUTCH LANE, Fairfield, NJ, United States
No problems found at FDA's last inspection, Jan 9, 2026.
No Action Indicated: inspectors found no objectionable conditions.
11 drug inspections on record since 2009: 8 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 9, 2026 | No problems found | Drug Quality Assurance | — |
| Feb 18, 2022 | No problems found | Drug Quality Assurance | — |
| Jan 24, 2019 | No problems found | Drug Quality Assurance | — |
| Sep 27, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 16, 2016 | No problems found | Bioresearch Monitoring | — |
| May 4, 2015 | Problems found, fixed voluntarily | Bioresearch Monitoring | 1 |
| Sep 29, 2014 | No problems found | Drug Quality Assurance | — |
| Oct 22, 2013 | No problems found | Drug Quality Assurance | — |
| Nov 15, 2012 | No problems found | Drug Quality Assurance | — |
| Mar 24, 2010 | No problems found | Drug Quality Assurance | — |
| Jul 7, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
May 4, 2015 inspection
- Late submission of quarterly safety reports 21 CFR 314.80(c)(2)
Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter.
Registered with FDA for: analysis; label; manufacture; pack.