FDA Inspection
U-systems IncU-systems Inc – FDA Inspection, Sep 10, 2013
Record Details
This FDA Inspection record concerns U-systems Inc, with an inspection on September 10, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- U-systems Inc
- Inspection Date
- September 10, 2013
- Product Type
- Devices
View Company Profile
ID · 50c67c18-1822-4318-9930-91dc43937412
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 849549
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.200(d)Service reports
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 |
| January 26, 2012 | 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 766597 - 2012-01-26
- FDA Inspection 546257 - 2008-10-30
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