Company
United StatesAffymetrix, Warrensville Heights, OH – FDA Inspections
Inspection records and compliance data for Affymetrix in Warrensville Heights, Ohio. 3 FDA inspections on record, last inspected April 22, 2016.
Company Profile
This profile covers Affymetrix based in Warrensville Heights, Ohio, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected September 26, 2012. Last inspected April 22, 2016.
Most cited issue areas
- Documentation2 inspections
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 22, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 969285 |
| April 1, 2016 | NAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 964568 |
| September 26, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 799542 |
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
FEI Number
3008715426
Address
26111 Miles Rd, Warrensville Heights, Ohio 44128, United States
Country
United States
ID: f7b2e1fc-3b66-4488-ad33-61a5b0b772c1