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Don Bark InspectorProfile

$995 - Available for instant download

This FDA InspectorProfile is a report of relevant audit-related information on Don Bark, 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 Don Bark's inspections in 11 countries: Canada, Germany, Italy, Finland, Netherlands, Spain, Denmark, Ireland, United States, United Kingdom, and Switzerland.

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 Don Bark's inspection information so that you can mitigate investigator-related risks.

Example Report

Below is an example of what a FDAzilla InspectorProfile report contains; This is not the actual data for Don Bark.

FDA InspectorProfile Overview Example
FDA InspectorProfile Metrics Example
FDA InspectorProfile Citations Example
FDA InspectorProfile Inspections List

Product details

  • Don Bark'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) Don Bark has conducted including:

Note: The EIR and 483 documents are sold separately.