FDA Inspection
U-systems IncU-systems Inc – FDA Inspection, Oct 30, 2008
Record Details
This FDA Inspection record concerns U-systems Inc, with an inspection on October 30, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- U-systems Inc
- Inspection Date
- October 30, 2008
- Product Type
- Devices
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ID · 5217673a-5d1f-4e03-9113-4325cb8f8c4d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 546257
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.30(f)Design verification procedures
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Other FDA inspections of U-systems Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 31, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 10, 2013 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| January 26, 2012 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for U-systems Inc
- FDA Inspection 1006662 - 2017-03-31
- FDA Inspection 849549 - 2013-09-10
- FDA Inspection 766597 - 2012-01-26
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