Company
United StatesSpinal Elements, Marietta, GA – FDA Inspections
Inspection records and compliance data for Spinal Elements in Marietta, Georgia. 5 FDA inspections on record, 1 Form 483, last inspected September 28, 2017.
Company Profile
This profile covers Spinal Elements based in Marietta, Georgia, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected January 5, 2011. Last inspected September 28, 2017.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Lack of procedures, or not maintained1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 28, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1027047 |
| February 14, 2017 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1002009 |
| November 12, 2014 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 903639 |
| May 14, 2013 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 831620 |
| January 5, 2011 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 704867 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Spinal Elements
FEI Number
3007970248
Address
1755 W Oak Pkwy, Marietta, Georgia 30062, United States
Country
United States
ID: 7e708f23-b4fd-42dd-b474-1589e0e0b357