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 · 546938bb-ef9c-4665-9aa0-2440af4245aa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1099025
- 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.
11| 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 |
| 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 |
| December 23, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Fougera Pharmaceuticals Inc.
- FDA Inspection 1226533 - 2023-12-08
- FDA Inspection 1177370 - 2022-08-10
- FDA Inspection 1053495 - 2018-05-29
- FDA Inspection 992924 - 2016-11-10
- FDA Inspection 908064 - 2014-12-23
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