FDA Inspection 1304018 — Snap Diagnostics, LLC.
The FDA completed an inspection of Snap Diagnostics, LLC. on February 13, 2026 in Vernon Hills, IL. 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
- February 13, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Vernon Hills, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23237 | ISO 13485:2016 Clause 8.3.1 | Procedure for nonconforming product not documented |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |