Company
United StatesSpinal Elements, Inc, Carlsbad, CA – FDA Inspections
Inspection records and compliance data for Spinal Elements, Inc in Carlsbad, California. 5 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected September 08, 2025.
Company Profile
This profile covers Spinal Elements, Inc based in Carlsbad, California, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 0
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected August 30, 2013. Last inspected September 8, 2025.
Most cited issue areas
- Design verification - Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 8, 2025 | Not classified | Biologics | 1281830 |
| May 14, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1095313 |
| September 29, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1028593 |
| January 15, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 863246 |
| August 30, 2013 | NAI | Biologics, Medical Devices & Rad Health · Postmarket Assurance: Devices | 846624 |
FDA documents
Warning Letters (1)
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Spinal Elements, Inc
FEI Number
3004893332
Address
3115 Melrose Dr Ste 200, Carlsbad, California 92010, United States
Country
United States
ID: 1d3f3e20-8afa-493e-8378-f9c933fcb052