FDA Inspection 1192261 — AdDent, Inc.

AdDent, Inc. — FEI 3003694926

The FDA completed an inspection of AdDent, Inc. on December 8, 2022 in Danbury, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 8, 2022
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Danbury, CT (United States)

Citations

IDCFRDescription
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures