FDA 483 - Hampton Medical Devices, LLC - November 08, 2021

Hampton Medical Devices, LLC in Festus, MO, was inspected by the FDA, revealing significant deficiencies in its quality system for medical device manufacturing. The inspection identified repeated violations across multiple areas, including process validation, contamination control, corrective and preventive actions, record keeping, equipment calibration, and quality audits. These issues indicate a systemic failure to maintain adequate control over manufacturing processes and product quality.