FDA Inspection
Corden Pharma Fribourg SACorden Pharma Fribourg SA – FDA Inspection, Feb 3, 2023
Record Details
This FDA Inspection record concerns Corden Pharma Fribourg SA, with an inspection on February 3, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f32fd49c-45a8-454c-855a-5251409e97b1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1197386
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Corden Pharma Fribourg SA
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 15, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 5, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 28, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Corden Pharma Fribourg SA
- FDA Inspection 1061458 - 2018-06-15
- FDA Inspection 883319 - 2014-06-05
- FDA Inspection 802561 - 2012-06-28
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