KJB

Karen Bak InspectorProfile

$695.00

This InspectorProfile is a report of relevant audit-related information on Karen Bak, 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 Bak's 395 inspections in 2 countries: United States, and Costa Rica.

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 Bak'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 Bak.

Example Report

Karen Bak FDA InspectorProfile Overview Example
Karen Bak FDA InspectorProfile Metrics Example
Karen Bak FDA InspectorProfile Citations Example
Karen Bak FDA InspectorProfile Inspections List
Add To Cart3 of Bak 483s in stock

Product details

  • Karen Bak'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 Bak has conducted including:

Note: The EIR and 483 documents are sold separately.

Add To Cart3 of Karen's 483s Available Now.