West Medical Supplies – FDA 483, May 26, 2026

West Medical Supplies, an importer and distributor of high-risk Class II and III medical devices in Hallandale Beach, FL, was cited for significant quality management system deficiencies. The inspection revealed a systemic failure to control nonconforming products, evaluate suppliers, establish foundational QMS documentation, and adequately control QMS documents, posing a direct and serious risk to patient safety. The firm distributed nonconforming devices, including those with foreign language labeling, without proper detection or control.