FEI 1000118628
Five Star Orthodontic Laboratory & Supply, Inc.
2928 Metro Street, Denton, TX, US
MDR events0All time
Recalls0All time
Registered products24
Establishment typeManufactureManufacture Medical Device
Registered product codes
24 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 1000118628.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Mar 17, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Mar 17, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
8 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.198(a)Mar 17, 2025
Complaints
- 21 CFR 806.20(a)Mar 17, 2025
Records not kept
- 21 CFR 820.25(b)Mar 17, 2025
Training - Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Mar 17, 2025
Acceptable supplier records, inadequate records
- 21 CFR 820.70(g)(1)Mar 17, 2025
Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.100(b)Mar 17, 2025
Documentation
- 21 CFR 820.180Mar 17, 2025
Availability
- 21 CFR 820.184Mar 17, 2025
DHR - not or inadequately maintained
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.