FDA Inspection 1255858 — UCP Bioscience Inc
The FDA completed an inspection of UCP Bioscience Inc on Nov 18, 2024 in Milpitas, CA. 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 18, 2024
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Milpitas, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |