FDA 483 - Apolo - Megasun LLC - August 29, 2024

An FDA inspection of Apolo Megasun LLC, a manufacturer of photobiomodulation tables/beds, was conducted from August 27-29, 2024. The inspection revealed multiple significant deficiencies in the firm's quality management system. Main violations included the absence of adequate procedures for finished device acceptance; specifically, certain devices failed amperage tests without documented correction or nonconformance reports, and one device model lacked defined performance specifications. The company also failed to apply Unique Device Identifier (UDI) labeling to its Class II medical devices, a requirement under federal regulations. Furthermore, procedures for the routine calibration of critical measuring equipment, such as amperage and light intensity meters, were inadequate, lacking essential records of calibration dates, responsible vendors, and next scheduled calibrations. A critical observation noted the complete lack of established design control procedures for their Class II medical devices, encompassing key elements like design planning, input, output, verification, risk analysis, design transfer, and design review. Apolo Megasun LLC committed to correcting all identified observations, indicating a need for comprehensive improvements to their quality system to ensure compliance with medical device regulatory requirements.