FDA 483 - RESTECH, dba Mederi RF LLC - September 18, 2024

RESTECH, dba Mederi RF LLC, in Houston, TX, was inspected regarding its medical device manufacturing processes, specifically for the STRETTA Catheter System. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate design change procedures, incorrect translation of design into production specifications, and failures in corrective and preventive actions. Additionally, the firm's software validation practices for both its quality management system and device software were found to be insufficient, leading to potential device functionality issues.