Company
United StatesUnified Spine, Llc, Westerville, OH – FDA Inspections
Inspection records and compliance data for Unified Spine, Llc in Westerville, Ohio. 5 FDA inspections on record, last inspected March 01, 2024.
Company Profile
This profile covers Unified Spine, Llc based in Westerville, Ohio, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected November 18, 2011. Last inspected March 1, 2024.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Installer records1 inspection
- Procedures not adequately established or maintained1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 1, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1233724 |
| December 4, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1114511 |
| July 6, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1020853 |
| August 23, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 983542 |
| November 18, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 754612 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Unified Spine, Llc
FEI Number
3006215390
Address
6295 Maxtown Rd Ste 500, Westerville, Ohio 43082, United States
Country
United States
ID: 8486d3fb-026d-4161-9a31-a1e7a0ffd074