FDA 483 - Intego Software LLC - April 24, 2024

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from April 22-24, 2025, Intego Software LLC, a manufacturer located in Jacksonville, FL, received a Form FDA 483 detailing significant observations related to its quality management system. The inspection revealed four primary issues, indicating a lack of robust regulatory compliance with FDA quality system requirements.

Firstly, the company lacked adequately established procedures for Corrective and Preventive Actions (CAPA), a critical component for addressing and preventing quality deficiencies. Secondly, Intego Software LLC did not have formal procedures in place for receiving, reviewing, and evaluating customer complaints, which is essential for product safety and quality monitoring.

Furthermore, management with executive responsibility failed to conduct and document required reviews of the quality system's suitability and effectiveness for the years 2022, 2023, and 2024, as mandated by their own Quality Management System Manual. Similarly, the firm neglected to perform necessary quality audits for 2022 and 2024, a key practice for ensuring ongoing compliance and system effectiveness. The company has indicated a commitment to correct these identified issues.