FDA Inspection 1264075 — Biopharm Uk Ltd
The FDA completed an inspection of Biopharm Uk Ltd on Mar 19, 2025 in Swansea. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 19, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Swansea (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |