FDA Inspection
Genesis Northwest, IncorporatedGenesis Northwest, Incorporated – FDA Inspection, Aug 5, 2009
Record Details
This FDA Inspection record concerns Genesis Northwest, Incorporated, with an inspection on August 5, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 5, 2009
- Product Type
- Devices
View Company Profile
ID · 65ec8d92-50c6-40d4-951c-446d88289ae5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 601998
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.160(a)Control/distribution procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.90(b)(1)Documentation of disposition, justification, signature
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Genesis Northwest, Incorporated
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 18, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 30, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Genesis Northwest, Incorporated
- FDA Inspection 914219 - 2015-02-13
- FDA Inspection 813365 - 2013-01-18
- FDA Inspection 701973 - 2010-11-30
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