Company
United StatesAurora Spine Inc, Carlsbad, CA – FDA Inspections
Inspection records and compliance data for Aurora Spine Inc in Carlsbad, California. 3 FDA inspections on record, 1 Form 483, last inspected July 30, 2018.
Company Profile
This profile covers Aurora Spine Inc based in Carlsbad, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 23, 2014. Last inspected July 30, 2018.
Most cited issue areas
- Design verification - output does not meet input requirement1 inspection
- Documentation of validated process performance1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 30, 2018 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1063919 |
| September 18, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1028588 |
| May 23, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 881967 |
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
Aurora Spine Inc
FEI Number
3010326971
Address
1930 Palomar Point Way Ste 103, Carlsbad, California 92008, United States
Country
United States
ID: 6cced3a5-bedd-4799-817d-422095631796