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Shelagh Schopen InspectorProfile

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This FDA InspectorProfile is a report of relevant audit-related information on Shelagh Schopen, 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 Shelagh Schopen's inspections in 6 countries: United States, Thailand, Korea, Republic Of (South), Brazil, Vietnam, and Australia.

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 Shelagh Schopen's inspection information so that you can mitigate investigator-related risks.

Example Report

Below is an example of what a FDAzilla InspectorProfile report contains; This is not the actual data for Shelagh Schopen.

FDA InspectorProfile Overview Example
FDA InspectorProfile Metrics Example
FDA InspectorProfile Citations Example
FDA InspectorProfile Inspections List

Product details

  • Shelagh Schopen'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) Shelagh Schopen has conducted including:

Note: The EIR and 483 documents are sold separately.