FDA Inspection
AffymetrixAffymetrix – FDA Inspection, Sep 26, 2012
Record Details
This FDA Inspection record concerns Affymetrix, with an inspection on September 26, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Affymetrix
- Inspection Date
- September 26, 2012
- Product Type
- Devices
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ID · f796dbcb-8d4c-40de-a9b0-86c7b60694ad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 799542
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 806.20(a)Records not kept
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Other FDA inspections of Affymetrix
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 1, 2016 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Affymetrix
- FDA Inspection 969285 - 2016-04-22
- FDA Inspection 964568 - 2016-04-01
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