DHB

Don Bark InspectorProfile

$995.00

This 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 25 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.

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

Example Report

Don Bark FDA InspectorProfile Overview Example
Don Bark FDA InspectorProfile Metrics Example
Don Bark FDA InspectorProfile Citations Example
Don Bark FDA InspectorProfile Inspections List
Add To Cart5 of Bark 483s in stock

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.

Add To Cart5 of Don's 483s Available Now.