FDA Inspection
Fareva PauFareva Pau – FDA Inspection, Feb 26, 2013
Record Details
This FDA Inspection record concerns Fareva Pau, with an inspection on February 26, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Fareva Pau
- Inspection Date
- February 26, 2013
- Product Type
- Drugs
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ID · 7d0d590a-7c0e-45fd-83b3-d1505f0bdd84
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 821739
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.101(d)Verification of component addition
- 21 CFR 211.65(a)Equipment construction - reactive surfaces
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.80(a)Procedures To Be in Writing
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Other FDA inspections of Fareva Pau
9| Date | Classification | Office | Project area |
|---|---|---|---|
| November 5, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 10, 2019 | Not classified | Office of Inspections and Investigations | |
| April 27, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 13, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 10, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Fareva Pau
- FDA Inspection 1202791 - 2021-11-05
- FDA Inspection 1101981 - 2019-09-10
- FDA Inspection 1100335 - 2018-04-27
- FDA Inspection 1020864 - 2017-04-13
- FDA Inspection 946909 - 2015-06-10
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