FDA Inspection
AffymetrixAffymetrix – FDA Inspection, Apr 22, 2016
Record Details
This FDA Inspection record concerns Affymetrix, with an inspection on April 22, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Affymetrix
- Inspection Date
- April 22, 2016
- Product Type
- Devices
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ID · 5d90c166-ff5d-4823-9c77-6438c3ed5366
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 969285
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(a)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Affymetrix
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 1, 2016 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 26, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Affymetrix
- FDA Inspection 964568 - 2016-04-01
- FDA Inspection 799542 - 2012-09-26
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