FDA Inspection 899750 — Linemaster Switch Corporation

Linemaster Switch Corporation — FEI 3001592626

The FDA completed an inspection of Linemaster Switch Corporation on October 1, 2014 in Woodstock, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 1, 2014
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
Location
Woodstock, CT (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
63221 CFR 803.17(a)(2)Lack of System for Determining MDR Events