FDA 483 - Sky Medical Supplies and Equipments, LLC - September 17, 2021

An FDA inspection of Sky Medical Supplies and Equipments, LLC in Parkland, FL, an initial importer, revealed six significant observations. The firm failed to establish fundamental quality system procedures, including those for corrective and preventive actions, medical device reporting, complaint handling, device distribution, storage area control, and document control. These deficiencies indicate a severe lack of basic operational controls.