FDA Inspection
Fougera Pharmaceuticals Inc.Fougera Pharmaceuticals Inc. – FDA Inspection, Aug 10, 2022
Record Details
This FDA Inspection record concerns Fougera Pharmaceuticals Inc., with an inspection on August 10, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Fougera Pharmaceuticals Inc.
- Inspection Date
- August 10, 2022
- Product Type
- Drugs
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ID · ab3524e1-b973-473e-824e-3219c4ccf027
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1177370
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.94(a)Reactive/Additive/Absorptive Containers/Closures
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.160(b)Scientifically sound laboratory controls
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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 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 |
| 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 1099025 - 2019-08-08
- FDA Inspection 1053495 - 2018-05-29
- FDA Inspection 992924 - 2016-11-10
- FDA Inspection 908064 - 2014-12-23
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