FDA Inspection
Fougera Pharmaceuticals, Inc.Fougera Pharmaceuticals, Inc. – FDA Inspection, Aug 8, 2019
Record Details
This FDA Inspection record concerns Fougera Pharmaceuticals, Inc., with an inspection on August 8, 2019, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 80a088b2-2af0-4df6-a0d3-7c207ff25c29
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1099624
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Fougera Pharmaceuticals, Inc.
12| Date | Classification | Office | Project area |
|---|---|---|---|
| March 26, 2026 | Not classified | New York District Office | Drug Quality Assurance |
| November 17, 2023 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| August 10, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 29, 2018 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| November 10, 2016 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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