FDA Inspection 836092 — Pulpdent Corporation

Pulpdent Corporation — FEI 1215305

The FDA completed an inspection of Pulpdent Corporation on June 11, 2013 in Watertown, MA. 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
June 11, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Watertown, MA (United States)

Citations

IDCFRDescription
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures