Company
United StatesIntuitive Imaging Informatics LLC, Bell Canyon, CA – FDA Inspections
Inspection records and compliance data for Intuitive Imaging Informatics LLC in Bell Canyon, California. 4 FDA inspections on record, 1 Form 483, last inspected August 06, 2021.
Company Profile
This profile covers Intuitive Imaging Informatics LLC based in Bell Canyon, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected July 19, 2011. Last inspected August 6, 2021.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 6, 2021 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1148417 |
| July 26, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1061600 |
| February 2, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 912235 |
| July 19, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 735294 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
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Company Information
Name
Intuitive Imaging Informatics LLC
FEI Number
3003952936
Address
215 Saddlebow Rd, Bell Canyon, California 91307, United States
Country
United States
ID: f9859746-3605-4161-9530-df423cf91653