Silq Technologies Corporation – FDA 483, Oct 16, 2025

During an inspection conducted by the Food and Drug Administration (FDA) from October 14 to October 16, 2025, Silq Technologies Corporation was cited for significant deviations from federal medical device regulations. The inspection revealed two primary observations requiring corrective action. Firstly, the company failed to submit Medical Device Reports (MDRs) within the mandated 30-day timeframe. Specifically, Silq Technologies became aware of at least two malfunctions involving their Class II Urological Catheter since January 2023, where patients required medical intervention. Despite these serious incidents and the firm's own internal procedures outlining the reporting timelines, the necessary reports were not filed promptly. Secondly, procedures for design change were found to be inadequate. Silq Technologies distributed a substantial number of modified Urological Catheters without proper approval for a design change that was implemented by their contract manufacturer in November 2024. The firm proceeded with distributing these altered devices without completing the required regulatory review and approval processes, contravening both federal requirements and their established 'Design Control Program'. These observations indicate a need for Silq Technologies Corporation to enhance its compliance with quality system requirements for medical devices. The company has acknowledged these issues and committed to implementing corrective actions for both observations.