FDA 483 - AHA TECHNOLOGIES, INC. - October 14, 2025

AHA TECHNOLOGIES, INC. in Detroit, MI, a medical device manufacturer, was cited for ten significant quality system deficiencies during an FDA inspection. The firm failed to establish and maintain fundamental procedures across critical areas such as design control, complaint handling, non-conforming product, purchasing, corrective and preventive actions, management responsibility, and document control. Additionally, the inspection revealed a lack of risk analysis and non-compliance with Unique Device Identifier (UDI) requirements for its Class II medical devices.