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 InspectorProfile report is updated through and lists John Iwen's 569 inspections in 5 countries: United States, India, Canada, Norway, and Belgium.
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.
Below is an example of what a FDAzilla InspectorProfile report contains; This is not the actual data for John Iwen.
Note: The EIR and 483 documents are sold separately.Add To Cart3 of John's 483s Available Now.