FDA Inspection
AxoGen CorporationAxoGen Corporation – FDA Inspection, Feb 8, 2018
Record Details
This FDA Inspection record concerns AxoGen Corporation, with an inspection on February 8, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Barbara T. Carmichael (FDA Associated Person)
- Lisa A. Stura (Issuing Officer)
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ID · 76a73d00-71a5-4ef7-be89-665fff16aa4d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1040447
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of AxoGen Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 4, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for AxoGen Corporation
- FDA Inspection 1214536 - 2023-08-04
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