FDA Inspection 1074864 — HealthDent'l LLC

HealthDent'l LLC — FEI 3013411964

The FDA completed an inspection of HealthDent'l LLC on December 13, 2018 in Plainfield, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 13, 2018
Fiscal Year
2019
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Plainfield, IL (United States)

Citations

IDCFRDescription
407021 CFR 820.30(g)Design validation - documentation