1263959
Five Star Orthodontic Laboratory & Supply, Inc. — FEI 1000118628
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 17, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Denton, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3149 | 21 CFR 820.180 | Availability |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4208 | 21 CFR 806.20(a) | Records not kept |