This FDA InspectorProfile is a report of relevant audit-related information on Karen Kosar, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Human Drugs.
This InspectorProfile report is updated through and lists Karen Kosar's inspections in 15 countries: United States, Mexico, Germany, Sweden, France, Denmark, Hungary, United Kingdom, Canada, Dominican Republic (the), China, India, Italy, Estonia, and Poland.
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 Karen Kosar'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 Karen Kosar.
Note: The EIR and 483 documents are sold separately.