FEI 3008776780
Dynasthetics
3487 W 2100 S 300, Salt Lake City, UT, US
MDR events0All time
Recalls1All time
Registered products4
Establishment typeManufactureManufacture Medical Device
Registered product codes
4 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Compliance history
Matched by FEI 3008776780.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jan 11, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Jan 11, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.75(a)Jan 11, 2024
Lack of or inadequate process validation
- 21 CFR 820.80(c)Jan 11, 2024
Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.100(b)Jan 11, 2024
Documentation
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.