FDA Inspection
Fougera Pharmaceuticals LLCFougera Pharmaceuticals LLC – FDA Inspection, Oct 31, 2013
Record Details
This FDA Inspection record concerns Fougera Pharmaceuticals LLC, with an inspection on October 31, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Fougera Pharmaceuticals LLC
- Inspection Date
- October 31, 2013
- Product Type
- Drugs
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ID · eb4e3bed-5ec4-4271-94a1-155a94dcf91a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 857676
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.110(a)Written in-process control procedures
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Other FDA inspections of Fougera Pharmaceuticals LLC
12| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2026 | Not classified | New York District Office | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| 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 |
Other documents for Fougera Pharmaceuticals LLC
- FDA Inspection 1329668 - 2026-08-06
- FDA Inspection 1226533 - 2023-12-08
- FDA Inspection 1177370 - 2022-08-10
- FDA Inspection 1099025 - 2019-08-08
- FDA Inspection 1053495 - 2018-05-29
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