JAI

John Iwen InspectorProfile

$995

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 West Des Moines, IA, United States.

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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.

Product details

  • John Iwen's metrics:
    • 483 issue rate, total inspections, total 483s
    • Most common citations (based on CFR), CFR description, and citation frequency
    • Total inspections, total 483s
    • Longest / shortest inspection in duration - all time, last year
    • Total warning letters
  • Inspection details for each inspection (since 2000) John Iwen has conducted including:
    • Company, site inspected, duration of inspection
    • Co-inspectors like Scott Jepson, Jason Caballero, Michele Obert, year of last co-inspection, number of co-inspections
    • If a 483 issued, and whether or not it resulted in a warning letter.
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