Company
United StatesIris Diagnostics, Chatsworth, CA – FDA Inspections
Inspection records and compliance data for Iris Diagnostics in Chatsworth, California. 3 FDA inspections on record, last inspected December 16, 2015.
Company Profile
This profile covers Iris Diagnostics based in Chatsworth, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected November 16, 2011. Last inspected December 16, 2015.
Most cited issue areas
- Individual Report of Malfunction1 inspection
- Lack of or inadequate procedures1 inspection
- Report of risk to health1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 16, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 951542 |
| January 16, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 863178 |
| November 16, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 755008 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Iris Diagnostics
FEI Number
2023446
Address
9172 Eton Ave, Chatsworth, California 91311, United States
Country
United States
ID: 1b712d88-d0b1-4969-bca3-9440eb2fee59