This InspectorProfile is a report of relevant audit-related information on John Iwen, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Biologics.
This report is updated through , which is the date of John's last inspection in Joplin, MO, United States.
FDA audits are stressful. Whether you are issued a 483 depends largely on your compliance with GxP and predicate rules; but it can also depend on the Agency's current focus and the tendencies of your specific investigator(s). FDAzilla has curated John Iwen's inspection information so that you can mitigate investigator-related risks.