FDA Inspection
Tobii Dynavox LlcTobii Dynavox Llc – FDA Inspection, Dec 15, 2017
Record Details
This FDA Inspection record concerns Tobii Dynavox Llc, with an inspection on December 15, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 74670172-233f-4cd5-9296-3b52a842a69a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1037116
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.200(c)Service reports/MDRs/complaints
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