Warning Letter — Linemaster Switch Corporation
The FDA issued a Warning Letter to Linemaster Switch Corporation on May 27, 2026, following an inspection by the Center for Devices and Radiological Health (CDRH).
This action affects Linemaster Switch Corporation and its personnel responsible for regulatory compliance, quality assurance, and manufacturing operations.
The issuance of a Warning Letter by CDRH signifies that the FDA identified significant violations of regulatory requirements. While the specific violations are not detailed in the available excerpt, this typically suggests deficiencies in Quality Management System (QMS) regulations or manufacturing standards which could lead to further enforcement actions if not remediated. Regulatory professionals should monitor this case for insights into localized enforcement priorities within the device sector.
Quality and Regulatory teams should review existing Quality Management System (QMS) documentation and procedures to ensure they meet current regulatory standards and that corrective actions are sufficiently documented. Internal audits should be conducted to identify potential gaps in manufacturing control or documentation practices.
FDA Warning Letter issued to: Linemaster Switch Corporation. 05/27/2026 — Center for Devices and Radiological Health. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/linemaster-switch-corporation-730215-05272026
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