FDA Inspection
Oxus, Inc.Oxus, Inc. – FDA Inspection, Aug 1, 2011
Record Details
This FDA Inspection record concerns Oxus, Inc., with an inspection on August 1, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Oxus, Inc.
- Inspection Date
- August 1, 2011
- Product Type
- Devices
View Company Profile
ID · eab08887-ae35-4dc1-9d4d-554dee0dd0c2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 738375
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.50(b)Supplier notification of changes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Oxus, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 10, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 19, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 20, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Oxus, Inc.
- FDA Inspection 1106131 - 2019-10-10
- FDA Inspection 956232 - 2016-01-19
- FDA Inspection 848933 - 2013-09-20
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