FDA Inspection 1024479 — Viant AS&O Holdings, Llc

Viant AS&O Holdings, Llc — FEI 1832228

The FDA completed an inspection of Viant AS&O Holdings, Llc on August 30, 2017 in Indianapolis, IN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 30, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Indianapolis, IN (United States)

Citations

IDCFRDescription
311721 CFR 820.70(i)Software validation for automated processes
313021 CFR 820.100(a)Lack of or inadequate procedures
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ