FDA Inspection
InvaGen Pharmaceuticals, Inc.InvaGen Pharmaceuticals, Inc. – FDA Inspection, Dec 19, 2018
Record Details
This FDA Inspection record concerns InvaGen Pharmaceuticals, Inc., with an inspection on December 19, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ad18c385-4534-44c7-a720-62424b43a952
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1075033
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.110(b)In-process specification, invalid
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.82(b)Quarantine Storage of Components
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Other FDA inspections of InvaGen Pharmaceuticals, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2026 | Not classified | New York District Office | |
| September 19, 2023 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| May 26, 2017 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
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