FDA Inspection
Ingenus Pharmaceuticals NJ, LLC.Ingenus Pharmaceuticals NJ, LLC. – FDA Inspection, Dec 14, 2017
Record Details
This FDA Inspection record concerns Ingenus Pharmaceuticals NJ, LLC., with an inspection on December 14, 2017, issued by the New Jersey District Office, covering human drugs.
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ID · 679b7e75-2e47-4fd6-b003-0476840e6b30
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1035002
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(4)Test devices not meeting specifications
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Other FDA inspections of Ingenus Pharmaceuticals NJ, LLC.
12| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2026 | Not classified | New Jersey District Office | Compliance: Devices |
| January 9, 2026 | Not classified | New Jersey District Office | |
| February 18, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 24, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 27, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ingenus Pharmaceuticals NJ, LLC.
- FDA Inspection 1326668 - 2026-07-17
- FDA Inspection 1302128 - 2026-01-09
- FDA Inspection 1164226 - 2022-02-18
- FDA Inspection 1079060 - 2019-01-24
- FDA Inspection 1026727 - 2017-09-27
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