Company
United StatesIntelligent Retinal Imaging Systems Inc., Pensacola, FL – FDA Inspections
Inspection records and compliance data for Intelligent Retinal Imaging Systems Inc. in Pensacola, Florida. 1 FDA inspection on record, 1 Form 483, last inspected December 06, 2018.
Company Profile
This profile covers Intelligent Retinal Imaging Systems Inc. based in Pensacola, Florida, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected December 6, 2018.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Design validation - software validation documentation1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 6, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1074319 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Intelligent Retinal Imaging Systems Inc.
FEI Number
3011520729
Address
2 N Palafox St Ste 200, Pensacola, Florida 32502, United States
Country
United States
ID: fe1c6bbb-b3a2-47f4-b367-b684a2ef98d0