This FDA InspectorProfile is a report of relevant audit-related information on Paula Trost, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Biologics.
This InspectorProfile report is updated through and lists Paula Trost's inspections in 14 countries: Canada, United States, Switzerland, Sweden, Germany, France, Denmark, Ireland, Netherlands, United Kingdom, Belgium, Spain, Austria, and Italy.
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 Paula Trost'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 Paula Trost.
Note: The EIR and 483 documents are sold separately.