FDA 483 - R-Med Inc - April 23, 2025

R-Med Inc, a medical device manufacturer in Oregon, OH, was inspected by the FDA and received 10 observations, all of which were repeat observations from a previous inspection. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate complaint handling, control of nonconforming product, missing design and device history records, insufficient risk analysis, and a complete lack of quality audits and management reviews. These findings indicate severe and persistent non-compliance with quality system regulations.