FDA Inspection 1302172 — Collaborative Care Diagnostics, LLC.
The FDA completed an inspection of Collaborative Care Diagnostics, LLC. on February 9, 2026 in Eagan, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 9, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Eagan, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22796 | 21 CFR 801.40(a) | Form of a unique device identifier |
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23134 | ISO 13485:2016 Clause 7.3.9 | Review of design and development do not include evaluation of change effects |