FDA Inspection 572311 — Orthoscan, Inc.
The FDA completed an inspection of Orthoscan, Inc. on Mar 26, 2009 in Scottsdale, AZ. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 26, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Scottsdale, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3380 | 21 CFR 820.198(e)(6) | Results of investigation |
| 3414 | 21 CFR 820.200(d)(6) | Test and inspection data |
| 3428 | 21 CFR 820.50(a)(3) | Acceptable supplier records |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 5007 | 21 CFR 1002.13 | Failure to submit |