RGA

Robert Antonsen InspectorProfile

$795

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

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 Robert Antonsen'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 Robert Antonsen.

Example Report

Robert Antonsen FDA InspectorProfile Overview Example
Robert Antonsen FDA InspectorProfile Metrics Example
Robert Antonsen FDA InspectorProfile Citations Example
Robert Antonsen FDA InspectorProfile Inspections List
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Product details

  • Robert Antonsen'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) Robert Antonsen has conducted including:
    • Company, site inspected, duration of inspection
    • Co-inspectors like Janet Pulver FDA, 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.

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