FDA Inspection
InvaGen Pharmaceuticals, Inc.InvaGen Pharmaceuticals, Inc. – FDA Inspection, Sep 19, 2023
Record Details
This FDA Inspection record concerns InvaGen Pharmaceuticals, Inc., with an inspection on September 19, 2023, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · bcdad572-3ffb-4796-b39c-4a3ad562402b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1218990
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.122(a)Sampling/testing of labeling/packaging materials
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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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 | |
| December 19, 2018 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| May 26, 2017 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
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