1304018

Snap Diagnostics, LLC. — FEI 3000215335

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

IDCFRDescription
23087ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
23237ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
23255ISO 13485:2016 Clause 8.5.2Corrective action not taken