This FDA InspectorProfile is a report of relevant audit-related information on Kathleen Swat, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Biologics.
This InspectorProfile report is updated through and lists Kathleen Swat's inspections in 13 countries: United States, France, Czech Republic, Korea, Republic Of (South), United Kingdom, Germany, Italy, South Africa, Spain, Israel, India, Thailand, and Vietnam.
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 Kathleen Swat'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 Kathleen Swat.
Note: The EIR and 483 documents are sold separately.