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Sonya Karsik InspectorProfile

$795.00

This InspectorProfile is a report of relevant audit-related information on Sonya Karsik, 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 Sonya Karsik's 305 inspections in 9 countries: United States, Canada, Mexico, China, France, Germany, Dominican Republic (the), Costa Rica, 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 Sonya Karsik'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 Sonya Karsik.

Example Report

Sonya Karsik FDA InspectorProfile Overview Example
Sonya Karsik FDA InspectorProfile Metrics Example
Sonya Karsik FDA InspectorProfile Citations Example
Sonya Karsik FDA InspectorProfile Inspections List
Add To Cart21 of Karsik 483s in stock

Product details

  • Sonya Karsik'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) Sonya Karsik has conducted including:

Note: The EIR and 483 documents are sold separately.

Add To Cart21 of Sonya's 483s Available Now.