961418

Koning Corporation — FEI 3008513054

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 10, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Norcross, GA (United States)

Additional Details

Postmarket Audit Inspections

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures