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Ernest Bizjak InspectorProfile

$995.00

This InspectorProfile is a report of relevant audit-related information on Ernest Bizjak, 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 Ernest Bizjak's 214 inspections in 12 countries: United States, Switzerland, Germany, France, United Kingdom, Belgium, Israel, Denmark, Argentina, Uruguay, Spain, and Monaco.

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 Ernest Bizjak'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 Ernest Bizjak.

Example Report

Ernest Bizjak FDA InspectorProfile Overview Example
Ernest Bizjak FDA InspectorProfile Metrics Example
Ernest Bizjak FDA InspectorProfile Citations Example
Ernest Bizjak FDA InspectorProfile Inspections List
Add To Cart15 of Bizjak 483s in stock

Product details

  • Ernest Bizjak'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) Ernest Bizjak has conducted including:

Note: The EIR and 483 documents are sold separately.

Add To Cart15 of Ernest's 483s Available Now.