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.
This InspectorProfile report is updated through 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.
Below is an example of what a FDAzilla InspectorProfile report contains; This is not the actual data for Michael Shanks.
Note: The EIR and 483 documents are sold separately.