FDA 483 - Advanced Cooling Therapy Inc. - October 22, 2021

An FDA inspection of Advanced Cooling Therapy Inc. in Chicago, IL, identified four significant deficiencies in their quality system for medical devices. The firm failed to ensure device manufacturing aligned with master records, promptly investigate MDR reportable complaints, document corrective actions, and establish adequate finished device acceptance procedures. These issues indicate a lack of robust quality control for their EnsoETM device.