FDA 483 - Nagl MedTech - September 20, 2022

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from September 12 to September 20, 2022, contract manufacturer Naglreiter Consulting, LLC received a Form FDA 483, detailing five significant observations. This document highlights potential deviations from good manufacturing practices and quality system requirements for medical devices. The observations primarily concern deficiencies in the company's quality management system. Specifically, the FDA noted that supplier requirements were not adequately established, with a contract manufacturer failing to validate a critical component manufacturing process, leading to multiple nonconformance reports. Furthermore, a crucial covering application process lacked adequate validation, as documentation focused on machine settings rather than process and product performance. Design control issues were also identified, including the absence of a required real-time aging study for shelf-life validation and an insufficient number of participants in a user-based design validation study. The firm's design risk analyses were deemed inadequate, failing to incorporate identified risks from component failures and using an inappropriate definition for failure effects. Finally, Device History Records did not consistently include results from all necessary in-process tests. These observations indicate the need for Naglreiter Consulting, LLC to promptly address these systemic quality deficiencies. The firm is responsible for evaluating these findings, implementing appropriate corrective actions, and submitting a response to the FDA to demonstrate compliance with regulatory expectations.