This FDA InspectorProfile is a report of relevant audit-related information on Stephen Souza, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Medical Devices & Rad Health.
This InspectorProfile report is updated through and lists Stephen Souza's inspections in 20 countries: United States, Australia, China, Singapore, Korea (the Republic of), Germany, Ireland, Canada, United Kingdom, Philippines, France, Switzerland, Taiwan, New Zealand, Italy, Romania, Brazil, Japan, Spain, and Austria.
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 Stephen Souza'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 Stephen Souza.
Note: The EIR and 483 documents are sold separately.