FDA Inspection 1198638 — Carolina Sports and Orthopedics Sales Inc
The FDA completed an inspection of Carolina Sports and Orthopedics Sales Inc on March 1, 2023 in North Charleston, SC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 1, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- North Charleston, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 21424 | 21 CFR 820.120(b) | Labeling inspection - UDI |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |