Michael Shanks InspectorProfile


This InspectorProfile is a report of relevant audit-related information on Michael Shanks, 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 Michael Shanks's 43 inspections in 13 countries: Switzerland , Ireland , United States , Korea (the Republic of) , Slovenia , India , Denmark , Austria , Germany , South Africa , Japan , Italy , and Poland .

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 Michael Shanks'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 Michael Shanks.

Example Report

Michael Shanks FDA InspectorProfile Overview Example
Michael Shanks FDA InspectorProfile Metrics Example
Michael Shanks FDA InspectorProfile Citations Example
Michael Shanks FDA InspectorProfile Inspections List
Add To Cart23 of Shanks 483s in stock

Product details

  • Michael Shanks'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) Michael Shanks has conducted including:

Note: The EIR and 483 documents are sold separately.

Add To Cart23 of Michael's 483s Available Now.