FDA Inspection 809981 — Primo Medical Group, Inc

Primo Medical Group, Inc — FEI 3009420598

The FDA completed an inspection of Primo Medical Group, Inc on December 10, 2012 in West Bridgewater, 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
December 10, 2012
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
West Bridgewater, MA (United States)

Citations

IDCFRDescription
1471121 CFR 820.160(a)Lack of or inadequate procedures for distribution