This FDA 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.
This InspectorProfile report is updated through and lists Sonya Karsik's inspections in 12 countries: United States, Canada, Mexico, China, France, Germany, Dominican Republic (the), Costa Rica, Switzerland, Korea (the Republic of), Japan, 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 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.
Note: The EIR and 483 documents are sold separately.