FDA Inspection 1048827 — TP Orthodontics, Inc.
The FDA completed an inspection of TP Orthodontics, Inc. on April 9, 2018 in La Porte, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 9, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- La Porte, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |