FDA Inspection
Fougera Pharmaceuticals, Inc.Fougera Pharmaceuticals, Inc. – FDA Inspection, Nov 17, 2023
Record Details
This FDA Inspection record concerns Fougera Pharmaceuticals, Inc., with an inspection on November 17, 2023, issued by the Center for Veterinary Medicine, covering veterinary.
- Person
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ID · 5047cfba-3bac-4e83-afac-6b55ffc1b9fc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1223760
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
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 |
| August 10, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 8, 2019 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| 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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