AWY

Amy Yan Mai InspectorProfile

$795

This 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.

Product Description

This InspectorProfile report is updated through and lists Amy Yan Mai's 209 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.

Example Report

Amy Yan Mai FDA InspectorProfile Overview Example
Amy Yan Mai FDA InspectorProfile Metrics Example
Amy Yan Mai FDA InspectorProfile Citations Example
Amy Yan Mai FDA InspectorProfile Inspections List
Add To Cart1 of Yan Mai 483s in stock

Product details

  • Amy Yan Mai'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) Amy Yan Mai has conducted including:

Note: The EIR and 483 documents are sold separately.

Add To Cart1 of Amy's 483s Available Now.