FDA Inspection
AXENA HEALTH, INC.AXENA HEALTH, INC. – FDA Inspection, Nov 14, 2018
Record Details
This FDA Inspection record concerns AXENA HEALTH, INC., with an inspection on November 14, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f3906501-52d3-4121-96b5-f27cccea28b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1071637
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
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