FDA WARNING_LETTER - Linemaster Switch Corporation - March 06, 2026

On May 27, 2026, the FDA issued a Warning Letter (CMS #730215) to Linemaster Switch Corporation following an inspection of its Woodstock, Connecticut, facility conducted between February 4 and March 6, 2026. The inspection identified significant quality management failures regarding the manufacture of foot pedal accessories used with medical lasers. Key violations included the failure to document product rework, a lack of risk management files for specific devices, and inadequate investigations into customer corrective action requests. Furthermore, the company failed to implement controls for the manufacturing environment—specifically temperature fluctuations that affect device calibration—and neglected to adequately validate software used during the testing and calibration process. These issues constitute violations of the Federal Food, Drug, and Cosmetic Act and the Quality Management System Regulation (21 CFR Part 820), which incorporates standards from ISO 13485:2016. The FDA has directed Linemaster to provide a written response within 15 business days outlining its corrective actions. This must include revised procedures, a summary of retrospective product reviews, and evidence of successful software revalidation. Continued failure to address these concerns may result in regulatory enforcement actions, such as product seizures, injunctions, or civil penalties.