FDA Inspection
Axiomed Spine CorporationAxiomed Spine Corporation – FDA Inspection, Feb 14, 2014
Record Details
This FDA Inspection record concerns Axiomed Spine Corporation, with an inspection on February 14, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Axiomed Spine Corporation
- Inspection Date
- February 14, 2014
- Product Type
- Devices
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ID · f36cbecb-f71f-41db-a963-786a019837e2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 866382
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.46(a)Sponsor securing investigator compliance
- 21 CFR 812.43(c)No investigator agreement
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