Company
United StatesAEGIS Spine, Inc., Costa Mesa, CA – FDA Inspections
Inspection records and compliance data for AEGIS Spine, Inc. in Costa Mesa, CA. 4 FDA inspections on record, last inspected May 18, 2017.
Company Profile
This profile covers AEGIS Spine, Inc. based in Costa Mesa, CA, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected August 30, 2013. Last inspected May 18, 2017.
Most cited issue areas
- All core requirements covered in program1 inspection
- Establishing a system1 inspection
- Procedures re complaints1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 18, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1012457 |
| May 9, 2017 | NAI | Biologics · Blood and Blood Products | 1010585 |
| March 19, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 871350 |
| August 30, 2013 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 847846 |
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
AEGIS Spine, Inc.
FEI Number
3009790163
Address
130 Mccormick Ave, Costa Mesa, CA 92626-3316, United States
Country
United States
ID: 68a925de-924a-4731-a838-28d9bcc39141