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Stephanie Shapley InspectorProfile

$995

This InspectorProfile is a report of relevant audit-related information on Stephanie Shapley, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Human Drugs.

Product Description

This InspectorProfile report is updated through and lists Stephanie Shapley's 144 inspections in 5 countries: United States , Finland , Russia , Italy , and Austria .

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 Stephanie Shapley'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 Stephanie Shapley.

Example Report

FDA InspectorProfile Overview Example
FDA InspectorProfile Metrics Example
FDA InspectorProfile Citations Example
FDA InspectorProfile Inspections List
Add To Cart17 of Shapley 483s in stock

Product details

  • Stephanie Shapley'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) Stephanie Shapley has conducted including:

Note: The EIR and 483 documents are sold separately.

Add To Cart17 of Stephanie's 483s Available Now.