FDA Inspection
Azena Medical, LLCAzena Medical, LLC – FDA Inspection, Oct 6, 2017
Record Details
This FDA Inspection record concerns Azena Medical, LLC, with an inspection on October 6, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 976b0c05-fca9-4c4e-bb23-23589308831a
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1028264
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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