Sean Duke InspectorProfile


This InspectorProfile is a report of relevant audit-related information on Sean Duke, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Foods & Cosmetics.

Product Description

This InspectorProfile report is updated through and lists Sean Duke's 193 inspections in 2 countries: United States, and Argentina.

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 Sean Duke'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 Sean Duke.

Example Report

Sean Duke FDA InspectorProfile Overview Example
Sean Duke FDA InspectorProfile Metrics Example
Sean Duke FDA InspectorProfile Citations Example
Sean Duke FDA InspectorProfile Inspections List
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Product details

  • Sean Duke'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) Sean Duke has conducted including:

Note: The EIR and 483 documents are sold separately.

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