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Dawn Olenjack InspectorProfile

$795.00

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

Product Description

This InspectorProfile report is updated through and lists Dawn Olenjack's 234 inspections in 12 countries: United States, Netherlands, Honduras, Italy, Canada, United Kingdom, Poland, India, Spain, France, Germany, and South Africa.

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 Dawn Olenjack'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 Dawn Olenjack.

Example Report

Dawn Olenjack FDA InspectorProfile Overview Example
Dawn Olenjack FDA InspectorProfile Metrics Example
Dawn Olenjack FDA InspectorProfile Citations Example
Dawn Olenjack FDA InspectorProfile Inspections List
Add To Cart19 of Olenjack 483s in stock

Product details

  • Dawn Olenjack'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) Dawn Olenjack has conducted including:

Note: The EIR and 483 documents are sold separately.

Add To Cart19 of Dawn's 483s Available Now.