FDA 483 - Heat In A Click LLC - January 24, 2025

Heat In A Click LLC, an importer and initial distributor of Class I and II medical devices in Dania, FL, received an FDA Form 483 citing numerous significant quality system deficiencies. The firm lacked established procedures for critical functions such as complaint handling, corrective and preventive actions, MDR reporting, supplier evaluations, acceptance activities, nonconforming product control, storage area management, and document control. Additionally, the company failed to implement Unique Device Identifier (UDI) requirements and provide necessary UDI information to the Global Unique Device Identification Database (GUDID).