FDA Inspection
U-systems IncU-systems Inc – FDA Inspection, Jan 26, 2012
Record Details
This FDA Inspection record concerns U-systems Inc, with an inspection on January 26, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- U-systems Inc
- Inspection Date
- January 26, 2012
- Product Type
- Devices
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ID · b9bfb018-16f6-4558-97db-bd629135810d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 766597
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.43(c)(5)No financial disclosure info in investigator agreement
- 21 CFR 812.25(e)Sponsor"s lack of written monitoring procedures
Full citation text and observation details available on the Dashboard.
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 |
| October 30, 2008 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for U-systems Inc
- FDA Inspection 1006662 - 2017-03-31
- FDA Inspection 849549 - 2013-09-10
- FDA Inspection 546257 - 2008-10-30
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