1216854

Cardionics, Inc — FEI 1629623

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 30, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Webster, TX (United States)

Citations

IDCFRDescription
235021 CFR 820.25(b)Training - Lack of or inadequate procedures
384121 CFR 820.90(b)(2)Product rework adverse effects {see also 820.184}