FDA Inspection 1263959 — Five Star Orthodontic Laboratory & Supply, Inc.
The FDA completed an inspection of Five Star Orthodontic Laboratory & Supply, Inc. on Mar 17, 2025 in Denton, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 8 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 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 |