Company
United StatesTobii Dynavox Llc, Coraopolis, PA – FDA Inspections
Inspection records and compliance data for Tobii Dynavox Llc in Coraopolis, Pennsylvania. 1 FDA inspection on record, 1 Form 483, last inspected December 15, 2017.
Company Profile
This profile covers Tobii Dynavox Llc based in Coraopolis, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected December 15, 2017.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Evaluation, timeliness, identification1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 15, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1037116 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Tobii Dynavox Llc
FEI Number
3004959902
Address
1400 Cherrington Pkwy, Coraopolis, Pennsylvania 15108-4356, United States
Country
United States
ID: 951517c6-2f9d-4f26-986f-7dded5e2d3d1