EFM

Edmund Mrak InspectorProfile

$995.00

This InspectorProfile is a report of relevant audit-related information on Edmund Mrak, 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 Edmund Mrak's 154 inspections in 14 countries: United States, Germany, Italy, Denmark, Sweden, India, China, Croatia, Austria, Switzerland, Spain, France, Korea (the Republic of), and Canada.

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 Edmund Mrak'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 Edmund Mrak.

Example Report

Edmund Mrak FDA InspectorProfile Overview Example
Edmund Mrak FDA InspectorProfile Metrics Example
Edmund Mrak FDA InspectorProfile Citations Example
Edmund Mrak FDA InspectorProfile Inspections List
Add To Cart47 of Mrak 483s in stock

Product details

  • Edmund Mrak'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) Edmund Mrak has conducted including:

Note: The EIR and 483 documents are sold separately.

Add To Cart47 of Edmund's 483s Available Now.