FDA 483 data is just the tip of the iceberg
AboutBlogFDA EmployeeOver 40,000+ FDA inspection documents: 483s, EIRs, 483Rs
inspectorprofile icon

Constance De Simone InspectorProfile

$995 - Available for instant download

This FDA InspectorProfile is a report of relevant audit-related information on Constance De Simone, 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 Constance De Simone's inspections in 1 countries: United States.

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 Constance De Simone'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 Constance De Simone.

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

Product details

  • Constance De Simone'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) Constance De Simone has conducted including:

Note: The EIR and 483 documents are sold separately.