Home / Inspections / 1306502

FDA Inspection 1306502 — Linemaster Switch Corporation

Linemaster Switch Corporation — FEI 3001592626

The FDA completed an inspection of Linemaster Switch Corporation on March 6, 2026 in Woodstock, CT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 6, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Woodstock, CT (United States)

Citations

IDCFRDescription
23069ISO 13485:2016 Clause 6.2Personnel competency not adequate
23080ISO 13485:2016 Clause 6.4.1Work environment requirements and procedures not documented
23087ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
23205ISO 13485:2016 Clause 7.6Software used for monitoring and measurement not validated
23236ISO 13485:2016 Clause 8.3.1Nonconforming product not identified and controlled
23255ISO 13485:2016 Clause 8.5.2Corrective action not taken

Facility

Other inspections at this facility

  • 1199731 (VAI Wed Feb 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1051163 (NAI Thu Apr 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 899750 (VAI Wed Oct 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 768698 (VAI Thu Jan 12 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources