Company
United StatesAffymetrix, Inc., Santa Clara, CA – FDA Inspections
Inspection records and compliance data for Affymetrix, Inc. in Santa Clara, California. 3 FDA inspections on record, last inspected March 15, 2016.
Company Profile
This profile covers Affymetrix, Inc. based in Santa Clara, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected October 14, 2011. Last inspected March 15, 2016.
Most cited issue areas
- Failure to submit, distinct marking1 inspection
- Justification for not reporting1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 15, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 977003 |
| July 29, 2015 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 935117 |
| October 14, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 752242 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Affymetrix, Inc.
FEI Number
3003314809
Address
3420 Central Expy, Santa Clara, California 95051, United States
Country
United States
ID: 4a218f28-9a1f-491d-944a-197d8c82d551