834546

AdDent, Inc. — FEI 3003694926

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 28, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Danbury, CT (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
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
63021 CFR 803.17Lack of Written MDR Procedures