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Stephen Smith InspectorProfile

$795.00

This InspectorProfile is a report of relevant audit-related information on Stephen Smith, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Medical Devices & Rad Health.

Product Description

This InspectorProfile report is updated through and lists Stephen Smith's 172 inspections in 10 countries: United States, China, Thailand, Korea (the Republic of), Japan, Australia, Malaysia, Taiwan, Germany, and United Kingdom.

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 Stephen Smith'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 Stephen Smith.

Example Report

Stephen Smith FDA InspectorProfile Overview Example
Stephen Smith FDA InspectorProfile Metrics Example
Stephen Smith FDA InspectorProfile Citations Example
Stephen Smith FDA InspectorProfile Inspections List
Add To Cart17 of Smith 483s in stock

Product details

  • Stephen Smith'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) Stephen Smith has conducted including:

Note: The EIR and 483 documents are sold separately.

Add To Cart17 of Stephen's 483s Available Now.