This FDA InspectorProfile is a report of relevant audit-related information on Amy Yan Mai, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Biologics.
This InspectorProfile report is updated through and lists Amy Yan Mai's inspections in 2 countries: United States, and Japan.
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 Amy Yan Mai'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 Amy Yan Mai.
Note: The EIR and 483 documents are sold separately.