FDA Inspection 895589 — Orthopedic Designs North America, Inc.
The FDA completed an inspection of Orthopedic Designs North America, Inc. on September 18, 2014 in Tampa, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 18, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 4209 | 21 CFR 806.20(b)(1) | Device name, identification |
| 4211 | 21 CFR 806.20(b)(3) | Events |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |