FDA 483 - Linemaster Switch Corporation - March 06, 2026

Linemaster Switch Corporation, a medical device manufacturer in Woodstock, CT, was inspected and cited for significant deficiencies in its quality system. Observations primarily focused on inadequate risk management, insufficient control of nonconforming products, failure to implement corrective actions, and poorly validated environmental controls and software for calibration. These issues pose a risk of unintended laser activation or inadequate laser power delivery from their foot pedal accessory devices.