FDA Inspection
Affymetrix, Inc.Affymetrix, Inc. – FDA Inspection, Jul 29, 2015
Record Details
This FDA Inspection record concerns Affymetrix, Inc., with an inspection on July 29, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Affymetrix, Inc.
- Inspection Date
- July 29, 2015
- Product Type
- Devices
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ID · f05fa103-009f-4568-ab46-19eb87748362
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 935117
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
2- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 1002.10Failure to submit, distinct marking
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Other FDA inspections of Affymetrix, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 15, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 14, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Affymetrix, Inc.
- FDA Inspection 977003 - 2016-03-15
- FDA Inspection 752242 - 2011-10-14
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