1100169

Centurion Medical Products, LP — FEI 1824619

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 20, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Howell, MI (United States)

Citations

IDCFRDescription
311721 CFR 820.70(i)Software validation for automated processes
312021 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
313021 CFR 820.100(a)Lack of or inadequate procedures
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation