ALF

Amanda Fyles InspectorProfile

$995.00

This InspectorProfile is a report of relevant audit-related information on Amanda Fyles, 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 Amanda Fyles's 12 inspections in 2 countries: United States, and Australia.

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 Amanda Fyles'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 Amanda Fyles.

Example Report

Amanda Fyles FDA InspectorProfile Overview Example
Amanda Fyles FDA InspectorProfile Metrics Example
Amanda Fyles FDA InspectorProfile Citations Example
Amanda Fyles FDA InspectorProfile Inspections List
Add To Cart8 of Fyles 483s in stock

Product details

  • Amanda Fyles'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) Amanda Fyles has conducted including:

Note: The EIR and 483 documents are sold separately.

Add To Cart8 of Amanda's 483s Available Now.