FDA Inspection
Fareva MirabelFareva Mirabel – FDA Inspection, Jan 19, 2016
Record Details
This FDA Inspection record concerns Fareva Mirabel, with an inspection on January 19, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Fareva Mirabel
- Inspection Date
- January 19, 2016
- Product Type
- Drugs
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ID · 2152b720-7fda-4b5d-9529-5552e5d5817b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 955347
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.56(b)Written sanitation procedures not followed
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Other FDA inspections of Fareva Mirabel
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 22, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 15, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 8, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 22, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 23, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Fareva Mirabel
- FDA Inspection 1271381 - 2022-07-22
- FDA Inspection 1124081 - 2019-03-15
- FDA Inspection 1054784 - 2018-06-08
- FDA Inspection 885746 - 2014-05-22
- FDA Inspection 732459 - 2011-05-23
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