FDA Inspection
Fareva PauFareva Pau – FDA Inspection, Jun 10, 2015
Record Details
This FDA Inspection record concerns Fareva Pau, with an inspection on June 10, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Fareva Pau
- Inspection Date
- June 10, 2015
- Product Type
- Drugs
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ID · f1b09712-8e3d-4b03-83c3-063584ac4ea7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 946909
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.42(c)(10)Aseptic Processing Area
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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 |
| February 26, 2013 | 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 821739 - 2013-02-26
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