FDA Inspection 1255471 — JB Medical Development LLC
The FDA completed an inspection of JB Medical Development LLC on Nov 19, 2024 in Sunrise, 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 19, 2024
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Sunrise, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |