FDA 483 - ENvue Medical (USA) Inc - August 29, 2025

During an inspection conducted by the FDA from August 26-29, 2025, ENvue Medical (USA) Inc., a specification developer for Class 2 medical devices, received a Form FDA-483 outlining two significant observations regarding its quality management system. The company was cited for not performing quality audits at defined intervals, specifically failing to conduct internal audits for 2023 and 2024, a requirement stipulated in its own procedure (EMP 6.1). Additionally, the inspection revealed that executive management had not reviewed the suitability and effectiveness of the quality system at defined intervals, as mandated by the company's procedure (EMP 1.1), with no management review meetings held in 2023 and 2024. These issues highlight non-adherence to internal quality system procedures, which are essential for maintaining compliance with regulatory standards for medical devices under the Federal Food, Drug and Cosmetic Act. ENvue Medical (USA) Inc. acknowledged both observations and committed to implementing corrective actions to address these deficiencies and ensure full compliance.