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InspectorProfile

$995 - Available for instant download

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

Product Description

This InspectorProfile report is updated through and lists 's inspections in 0 countries: .

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 '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 .

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

Product details

  • '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) has conducted including:
    • Company, site inspected, duration of inspection
    • Co-inspectors , year of last co-inspection, number of co-inspections
    • If a 483 issued, and whether or not it resulted in a warning letter.

Note: The EIR and 483 documents are sold separately.