Company
United StatesPublic company, NASDAQ: AXGNAxoGen Corporation (NASDAQ: AXGN), Alachua, FL – FDA Inspections
Inspection records and compliance data for AxoGen Corporation in Alachua, Florida. 2 FDA inspections on record, 1 Form 483, last inspected August 04, 2023. Publicly traded as NASDAQ: AXGN.
Company Profile
This profile covers AxoGen Corporation based in Alachua, Florida, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 8, 2018. Last inspected August 4, 2023.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 4, 2023 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1214536 |
| February 8, 2018 | VAI | Biologics, Medical Devices & Rad Health · Compliance: Devices | 1040447 |
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
AxoGen Corporation
Stock ticker
AXGN
Exchange
NASDAQ
Share price
$55.40
Market cap
$3.3B
Price as of
November 13, 2026
FEI Number
3006252977
Address
13631 Progress Blvd Ste 400, Alachua, Florida 32615, United States
Country
United States
ID: a43af3b1-a05c-440e-930c-a685952a6d70