FDA 483 - Paragonix Technologies Inc. - November 03, 2022

An FDA inspection of Paragonix Technologies Inc. in Braintree, MA, on November 2-3, 2022, identified one observation. The firm's procedures for receiving, reviewing, and evaluating complaints were found to be inadequately established. Specifically, issues were noted with complaint due dates and the inclusion of required information like UDIs or UPCs.