FDA Inspection
Genia Medical, Inc.Genia Medical, Inc. – FDA Inspection, Apr 17, 2017
Record Details
This FDA Inspection record concerns Genia Medical, Inc., with an inspection on April 17, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c9073e49-4077-4032-a501-9664cf5e0305
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012875
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Genia Medical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 15, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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