JAI

John Iwen InspectorProfile

$795.00

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.

Product Description

This InspectorProfile report is updated through and lists John Iwen's 568 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.

Example Report

John Iwen FDA InspectorProfile Overview Example
John Iwen FDA InspectorProfile Metrics Example
John Iwen FDA InspectorProfile Citations Example
John Iwen FDA InspectorProfile Inspections List
Add To Cart1 of Iwen 483s in stock

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:

Note: The EIR and 483 documents are sold separately.

Add To Cart1 of John's 483s Available Now.