Sharon Gundersen InspectorProfile


This InspectorProfile is a report of relevant audit-related information on Sharon Gundersen, 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 Sharon Gundersen's 108 inspections in 7 countries: United States, Germany, Netherlands, Austria, United Kingdom, France, and Finland.

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 Sharon Gundersen'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 Sharon Gundersen.

Example Report

Sharon Gundersen FDA InspectorProfile Overview Example
Sharon Gundersen FDA InspectorProfile Metrics Example
Sharon Gundersen FDA InspectorProfile Citations Example
Sharon Gundersen FDA InspectorProfile Inspections List
Add To Cart26 of Gundersen 483s in stock

Product details

  • Sharon Gundersen'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) Sharon Gundersen has conducted including:

Note: The EIR and 483 documents are sold separately.

Add To Cart26 of Sharon's 483s Available Now.