JC

Jacek Cieslak InspectorProfile

$995.00

This InspectorProfile is a report of relevant audit-related information on Jacek Cieslak, 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 Jacek Cieslak's 2 inspections in 2 countries: Korea (the Republic of), and Austria.

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 Jacek Cieslak'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 Jacek Cieslak.

Example Report

Jacek Cieslak FDA InspectorProfile Overview Example
Jacek Cieslak FDA InspectorProfile Metrics Example
Jacek Cieslak FDA InspectorProfile Citations Example
Jacek Cieslak FDA InspectorProfile Inspections List
Add To Cart1 of Cieslak 483s in stock

Product details

  • Jacek Cieslak'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) Jacek Cieslak has conducted including:
    • Company, site inspected, duration of inspection
    • Co-inspectors like Richard Ledwidge FDA, Ashar Parikh FDA, year of last co-inspection, number of co-inspections
    • If a 483 issued, and whether or not it resulted in a warning letter.

Note: The EIR and 483 documents are sold separately.

Add To Cart1 of Jacek's 483s Available Now.