FDA Inspection 1203778 — Toby Orthopaedics, Inc.
The FDA completed an inspection of Toby Orthopaedics, Inc. on Apr 28, 2023 in West Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 28, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- West Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |