This FDA InspectorProfile is a report of relevant audit-related information on Johann Fitch, 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 Johann Fitch's inspections in 11 countries: United States, Sweden, Canada, Argentina, Romania, Netherlands, Italy, Ukraine, Czech Republic, Bosnia-Hercegovina, and Spain.
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 Johann Fitch'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 Johann Fitch.
Note: The EIR and 483 documents are sold separately.