FDA Inspection
Fougera Pharmaceuticals Inc.Fougera Pharmaceuticals Inc. – FDA Inspection, Nov 16, 2012
Record Details
This FDA Inspection record concerns Fougera Pharmaceuticals Inc., with an inspection on November 16, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Fougera Pharmaceuticals Inc.
- Inspection Date
- November 16, 2012
- Product Type
- Drugs
View Company Profile
ID · a130196c-47fb-463d-95e7-1f5ddcadaeb7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 807660
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 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 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 Inc.
- 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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