Axogen Corporation
FDA inspection history in Vandalia, Ohio, 2025
- 1
- Form 483
Every document, by year
- Form 483
2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2025One Form 483, at Vandalia, Ohio.
Cited most
Across all Axogen observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.56Sanitation2
- 21 CFR 211.122Materials examination and usage criteria1
- 21 CFR 211.142Warehousing procedures1
The complete Axogen file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Vandalia, Ohio
One Form 483 · 2025 · 7 observations
Latest: Form 483, Apr 29, 2025 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-04-29 | 483 Form 483 | Vandalia, Ohio | 7 | $99 |
Investigators on these documents
FEI number 3023488176 · most recent document Apr 29, 2025
About Axogen Corporation
How many FDA Form 483s has Axogen Corporation received?
FDA Intel has 1 Form 483 on file for Axogen Corporation; the most recent is dated Apr 29, 2025.
When was Axogen Corporation last inspected by FDA?
The most recent FDA inspection document on file for Axogen Corporation is a Form 483 dated Apr 29, 2025, for the site in Vandalia, Ohio.
What did FDA cite at Axogen Corporation?
The regulations cited most in the observations on file for Axogen Corporation are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.42 (Design and construction features), 2 times; 21 CFR 211.56 (Sanitation), 2 times.