Emerald Supply Inc – FDA 483, Apr 16, 2026

Emerald Supply Inc, an initial importer of medical devices in Brooklyn, NY, received a Form FDA 483 with eight observations. The inspection revealed significant deficiencies across its quality management system, including failures in risk management, purchasing controls, complaint handling, supplier evaluation, and the establishment of essential quality system procedures. These issues indicate a lack of fundamental controls for ensuring the quality and safety of imported medical devices like AC-powered beds, patient lifters, and wheelchairs.