FDA 483 - APN Health LLC - September 01, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · f6a14edd-d2a2-4e59-a079-3aa7bab009c4