This FDA InspectorProfile is a report of relevant audit-related information on Stanley Eugene, 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 Stanley Eugene's inspections in 18 countries: United States, Korea (the Republic of), Taiwan, Switzerland, Germany, United Kingdom, Dominican Republic (the), Mexico, Canada, Denmark, Finland, Sweden, New Zealand, China, Malaysia, Thailand, Hungary, and Japan.
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 Stanley Eugene'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 Stanley Eugene.
Note: The EIR and 483 documents are sold separately.