Karen Spencer InspectorProfile


This InspectorProfile is a report of relevant audit-related information on Karen Spencer, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Foods & Cosmetics.

Product Description

This InspectorProfile report is updated through and lists Karen Spencer's 61 inspections in 1 countries: and United States.

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 Karen Spencer'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 Karen Spencer.

Example Report

Karen Spencer FDA InspectorProfile Overview Example
Karen Spencer FDA InspectorProfile Metrics Example
Karen Spencer FDA InspectorProfile Citations Example
Karen Spencer FDA InspectorProfile Inspections List
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Product details

  • Karen Spencer'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) Karen Spencer has conducted including:

Note: The EIR and 483 documents are sold separately.

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