FDA Inspection 1292098 — Resolution Biomedical Inc
The FDA completed an inspection of Resolution Biomedical Inc on November 19, 2025 in Tustin, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 19, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tustin, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22801 | 21 CFR 830.310(b) | GUDID Information required for unique device identification. |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3671 | 21 CFR 820.25(a) | Personnel |