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Yvins Dezan InspectorProfile

$995.00

This InspectorProfile is a report of relevant audit-related information on Yvins Dezan, 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 Yvins Dezan's 21 inspections in 2 countries: United States, 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 Yvins Dezan'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 Yvins Dezan.

Example Report

Yvins Dezan FDA InspectorProfile Overview Example
Yvins Dezan FDA InspectorProfile Metrics Example
Yvins Dezan FDA InspectorProfile Citations Example
Yvins Dezan FDA InspectorProfile Inspections List
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Product details

  • Yvins Dezan'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) Yvins Dezan has conducted including:
    • Company, site inspected, duration of inspection
    • Co-inspectors , 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.

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