Company
United StatesAspen Imaging Healthcare, Inc, Plano, TX – FDA Inspections
Inspection records and compliance data for Aspen Imaging Healthcare, Inc in Plano, TX. 2 FDA inspections on record, 2 Form 483s, last inspected August 19, 2026.
Company Profile
This profile covers Aspen Imaging Healthcare, Inc based in Plano, TX, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected January 26, 2023. Last inspected August 19, 2026.
Most cited issue areas
- Corrective action procedures not documented1 inspection
- Design and development of product not planned and controlled1 inspection
- Devices subject to device identification GUDID data submission requirements.1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 19, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1331626 |
| January 26, 2023 | Not classified | Medical Devices & Rad Health | 1197612 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Aspen Imaging Healthcare, Inc
FEI Number
3012624817
Address
801 Jupiter Rd Ste 200, Plano, TX 75074-7462, United States
Country
United States
ID: 739a0afe-02e5-4861-9ffb-00783d7b229b