FDA Inspection
InvaGen Pharmaceuticals, Inc.InvaGen Pharmaceuticals, Inc. – FDA Inspection, May 26, 2017
Record Details
This FDA Inspection record concerns InvaGen Pharmaceuticals, Inc., with an inspection on May 26, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c8bb9734-7b03-4b89-a738-871b57054f5d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1019854
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.22(c)Approve or reject procedures or specs
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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 |
| December 19, 2018 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
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