FDA Inspection 1327582 — Cancer Diagnostics Inc.
The FDA completed an inspection of Cancer Diagnostics Inc. on Jul 23, 2026 in Durham, NC. 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
- Jul 23, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Durham, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 23236 | ISO 13485:2016 Clause 8.3.1 | Nonconforming product not identified and controlled |