Shelagh Schopen InspectorProfile


This 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.

This report is updated through .

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.

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

Example Report

Shelagh Schopen FDA InspectorProfile Overview Example
Shelagh Schopen FDA InspectorProfile Metrics Example
Shelagh Schopen FDA InspectorProfile Citations Example
Shelagh Schopen FDA InspectorProfile Inspections List
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  • 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.

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