BSN Medical Inc – FDA 483, Sep 5, 2025

BSN Medical Inc., a specification developer and complaint file establishment in Charlotte, NC, underwent an FDA inspection from September 3-5, 2025. The inspection identified a significant recurring issue regarding the design validation of its Class II medical devices, specifically the Jobst forMen knee high and thigh high socks. The primary observation noted that the company failed to perform design validation activities on initial production units or their equivalents under actual or simulated use conditions, meaning the devices were not adequately verified to meet defined user needs. This report, issued under the Federal Food, Drug and Cosmetic Act, particularly Section 704(b), outlines these inspectional observations, which do not represent a final Agency determination of compliance. BSN Medical Inc. is responsible for conducting internal audits and correcting all quality system violations. The company has indicated a promise to correct the identified design validation deficiency and is expected to submit comprehensive corrective actions to the FDA.