FDA 483 - RevZero Inc - April 18, 2025

An FDA inspection of RevZero, Inc. in Chanhassen, MN, a device manufacturer, identified two significant observations. The firm's procedures for corrective and preventive actions were found to be inadequately established, resulting in failures to consistently identify actions, verify effectiveness, and maintain proper documentation. Additionally, the company lacked sufficient procedures for controlling nonconforming product, specifically regarding the evaluation for investigations and disposition by authorized personnel.