Company
United StatesTruAbutment Inc., Irvine, CA – FDA Inspections
Inspection records and compliance data for TruAbutment Inc. in Irvine, California. 2 FDA inspections on record (1 OAI), 1 Form 483, last inspected December 03, 2025.
Company Profile
This profile covers TruAbutment Inc. based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 21, 2025. Last inspected December 3, 2025.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Devices subject to device identification GUDID data submission requirements.1 inspection
- Label to bear a unique device identifier1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 3, 2025 | Not classified | Medical Devices & Rad Health | 1297270 |
| January 21, 2025 | OAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1258773 |
FDA documents
Form 483s (1)
People (2)
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
TruAbutment Inc.
FEI Number
3012422693
Address
Irvine, California 92614, United States
Country
United States
ID: ebfce720-ea1f-41bf-9914-20f12b72adf8