FDA 483 - RevZero Inc - April 18, 2025
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.
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.
ID · fb5e9e81-7f95-4937-9bbb-286e72c15210