Axogen Corporation
Form 483 issued April 29, 2025 · Vandalia, Ohio
- Inspection
- Apr 23 – Apr 29, 2025
- Investigators
- Jin Sung Hong· Miriam Ngundi· Verse Neetu Dahiya
- Observations
- 7
- Pages
- 5
- FEI number
- 3023488176
In short: On April 29, 2025, FDA issued a Form 483 with 7 observations to Axogen Corporation in Vandalia, Ohio (FEI 3023488176) after an inspection that ran Apr 23 – Apr 29, 2025. The investigators were Jin Sung Hong, Miriam Ngundi and Verse Neetu Dahiya. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Facilities & equipment and production account for 5 of 7 observations.
Most cited: 21 CFR 211.42 (2×) · 211.56 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures describing the warehousing of AVANCE final product, printed product labels, and retain…
- 02
Environmental monitoring program is deficient…
- 03
Manufacturing building used in the manufacture of AVANCE does not have the adequate…
- 04
Written procedures for production and process control are inadequate or not established to assure that the…
This inspection in context
Jin Sung Hong
2 documents · 2024–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in North Carolina.
The firmAxogen Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Axogen Corporation?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and materials. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Axogen Corporation?
Jin Sung Hong, Miriam Ngundi and Verse Neetu Dahiya are named on this Form 483, for the inspection of Apr 23 – Apr 29, 2025. Each investigator has a profile showing what they cite most.
When was Axogen Corporation inspected by FDA?
The inspection ran Apr 23 – Apr 29, 2025, and the Form 483 is dated April 29, 2025.
How do I get the full Form 483 for Axogen Corporation?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.