Laureen Geniusz InspectorProfile


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

Product Description

This InspectorProfile report is updated through and lists Laureen Geniusz's 281 inspections in 11 countries: United States, Austria, Germany, Canada, Costa Rica, United Kingdom, Sweden, Poland, Brazil, Dominican Republic (the), and Italy.

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 Laureen Geniusz'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 Laureen Geniusz.

Example Report

Laureen Geniusz FDA InspectorProfile Overview Example
Laureen Geniusz FDA InspectorProfile Metrics Example
Laureen Geniusz FDA InspectorProfile Citations Example
Laureen Geniusz FDA InspectorProfile Inspections List
Add To Cart101 of Geniusz 483s in stock

Product details

  • Laureen Geniusz'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) Laureen Geniusz has conducted including:

Note: The EIR and 483 documents are sold separately.

Add To Cart101 of Laureen's 483s Available Now.