913076

Ferno-Washington Inc — FEI 1523574

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 11, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Wilmington, OH (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
316021 CFR 820.184Lack of or inadequate DHR procedures
326221 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
337521 CFR 820.198(e)Records of complaint investigation
73121 CFR 803.50(a)(1)Report of Death or Serious Injury