FDA Inspection 1107144 — Premium Plus Dental Supplies Inc.

Premium Plus Dental Supplies Inc. — FEI 3004425647

The FDA completed an inspection of Premium Plus Dental Supplies Inc. on October 18, 2019 in Brooklyn, NY. 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
October 18, 2019
Fiscal Year
2020
Product Type
Devices
Project Area
Compliance: Devices
Location
Brooklyn, NY (United States)

Citations

IDCFRDescription
63021 CFR 803.17Lack of Written MDR Procedures