FDA Inspection
Tobii Assistive Technology, Inc.Tobii Assistive Technology, Inc. – FDA Inspection, Oct 8, 2010
Record Details
This FDA Inspection record concerns Tobii Assistive Technology, Inc., with an inspection on October 8, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 8, 2010
- Product Type
- Devices
View Company Profile
ID · 60b2e59f-ea7b-42b3-971e-70fa90509382
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 698660
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.198(a)Complaints
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Tobii Assistive Technology, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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