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Rachael Cook InspectorProfile

$995

This InspectorProfile is a report of relevant audit-related information on Rachael Cook, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Human Drugs.

This report is updated through .

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 Rachael Cook'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 Rachael Cook.

Example Report

Rachael Cook FDA InspectorProfile Overview Example
Rachael Cook FDA InspectorProfile Metrics Example
Rachael Cook FDA InspectorProfile Citations Example
Rachael Cook FDA InspectorProfile Inspections List
Add To CartRachael Cook 483s

Product details

  • Rachael Cook'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) Rachael Cook has conducted including:
    • Company, site inspected, duration of inspection
    • Co-inspectors like Constance Fears FDA, Tamara Henderson FDA, year of last co-inspection, number of co-inspections
    • If a 483 issued, and whether or not it resulted in a warning letter.

Note: The EIR and 483 documents are sold separately.

Add To CartRachael Cook 483s