AMK

Alexander Kay InspectorProfile

$795.00

This InspectorProfile is a report of relevant audit-related information on Alexander Kay, 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 Alexander Kay's 377 inspections in 10 countries: United States, India, Thailand, Ecuador, Dominican Republic, Dominican Republic (the), Poland, Bulgaria, Russia, and China.

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 Alexander Kay'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 Alexander Kay.

Example Report

Alexander Kay FDA InspectorProfile Overview Example
Alexander Kay FDA InspectorProfile Metrics Example
Alexander Kay FDA InspectorProfile Citations Example
Alexander Kay FDA InspectorProfile Inspections List
Add To Cart14 of Kay 483s in stock

Product details

  • Alexander Kay'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) Alexander Kay has conducted including:

Note: The EIR and 483 documents are sold separately.

Add To Cart14 of Alexander's 483s Available Now.