EJ

Edward Janik InspectorProfile

$795.00

This InspectorProfile is a report of relevant audit-related information on Edward Janik, 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 Edward Janik's 353 inspections in 15 countries: United States, Canada, Germany, Spain, Korea (the Republic of), Japan, Switzerland, Italy, India, United Kingdom, Russia, Israel, Ireland, Malaysia, and Taiwan.

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 Edward Janik'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 Edward Janik.

Example Report

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

Product details

  • Edward Janik'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) Edward Janik has conducted including:

Note: The EIR and 483 documents are sold separately.

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