Michael Shanks InspectorProfile

This FDA 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 Jan 2023 and lists Michael Shanks's inspections in 14 countries: Switzerland, Ireland, United States, Korea (the Republic of), Slovenia, India, Denmark, Austria, Germany, South Africa, Japan, Italy, Poland, and Israel.

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.

Example Report

Below is an example of what a FDAzilla InspectorProfile report contains; This is not the actual data for Michael Shanks.

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:
  • Company, site inspected, duration of inspection
  • Co-inspectors Virginia Carroll, Santiago Gallardo Johnson, Jacek Cieslak, Ashley Queen, Cheryl Clausen, year of last co-inspection, number of co-inspections
  • If a 483 issued, and whether or not it resulted in a warning letter.

Note: The EIR and 483 documents are sold separately.