FDA 483 - Insightra Medical Inc - January 27, 2025

Insightra Medical Inc. in Clarksville, TN, was cited with three observations during an FDA inspection from January 21-27, 2025. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding inadequate documentation of corrective and preventive actions, poorly maintained customer complaint files, and failures to adequately establish and implement design change procedures. These issues, many of which are repeat observations from previous inspections, indicate a systemic lack of control over critical quality processes for medical devices.