FDA Inspection 764019 — Advanced Dental Designs

Advanced Dental Designs — FEI 3007081532

The FDA completed an inspection of Advanced Dental Designs on January 24, 2012 in Riverside, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 24, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Riverside, CA (United States)

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
317021 CFR 820.198(b)Review and evaluation for investigation
333121 CFR 820.181DMR - not or inadequately maintained