FDA Inspection
Fougera Pharmaceuticals Inc.Fougera Pharmaceuticals Inc. – FDA Inspection, Jan 12, 2010
Record Details
This FDA Inspection record concerns Fougera Pharmaceuticals Inc., with an inspection on January 12, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Fougera Pharmaceuticals Inc.
- Inspection Date
- January 12, 2010
- Product Type
- Drugs
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ID · 95c8c0cd-86ce-4b33-82ef-7690430c6b81
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 636203
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
16- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.194(a)(7)Signatures and dates--person who performs test
Showing 10 of 16 citations.
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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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