FDA Inspection
Fougera Pharmaceuticals LLCFougera Pharmaceuticals LLC – FDA Inspection, Aug 6, 2026
Record Details
This FDA Inspection record concerns Fougera Pharmaceuticals LLC, with an inspection on August 6, 2026, issued by the New York District Office, covering animal drugs & feeds.
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ID · fb26d17b-04df-42ff-9c9f-fd501cc56aa9
Inspection Facts
- Inspection number
- 1329668
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.68(b)Backup file not maintained
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Other FDA inspections of Fougera Pharmaceuticals LLC
12| Date | Classification | Office | Project area |
|---|---|---|---|
| December 8, 2023 | NAI | Center for Drug Evaluation and Research | 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 Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Fougera Pharmaceuticals LLC
- FDA Inspection 1226533 - 2023-12-08
- FDA Inspection 1177370 - 2022-08-10
- FDA Inspection 1099025 - 2019-08-08
- FDA Inspection 1053495 - 2018-05-29
- FDA Inspection 992924 - 2016-11-10
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