FDA 483 - Athena GTX Inc. - April 21, 2022

An FDA inspection of Athena GTX Inc. in Johnston, IA, identified two significant observations. The firm lacked adequate procedures for monitoring and controlling process parameters, specifically for verifying unique device identifier (UDI) or universal product code (UPC) information. Additionally, procedures for receiving, reviewing, and evaluating complaints were not adequately established, with a specific SOP missing instructions for evaluating Medical Device Reportability.