1020611

American Dental Implant Corporation — FEI 3004595327

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 26, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
New Castle, PA (United States)

Citations

IDCFRDescription
237121 CFR 820.30(a)Design control - no procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
316821 CFR 820.198(a)Complaints
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
63021 CFR 803.17Lack of Written MDR Procedures