FDA 483 - APN Health LLC - September 01, 2023

APN Health LLC, a medical device manufacturer in Waukesha, WI, was cited for numerous quality system deficiencies related to its Navik 3D cardiac mapping system. The inspection revealed systemic failures in controlling nonconforming product, managing corrective and preventive actions, handling customer complaints, and ensuring proper labeling. Additionally, the firm lacked adequate procedures for supplier control, finished device acceptance, software validation, design risk analysis, and design change, indicating a broad breakdown in its quality management system.