This FDA InspectorProfile is a report of relevant audit-related information on Robert Tollefsen, 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 Robert Tollefsen's inspections in 18 countries: United States, Australia, Sweden, United Kingdom, Singapore, Japan, Ireland, Israel, Spain, Germany, Canada, Belgium, India, China, Jordan, Oman, Switzerland, and France.
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 Robert Tollefsen'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 Robert Tollefsen.
Note: The EIR and 483 documents are sold separately.