This InspectorProfile is a report of relevant audit-related information on Gene Arcy, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Biologics.
This InspectorProfile report is updated through and lists Gene Arcy's 336 inspections in 9 countries: United States , India , Belgium , United Kingdom , Switzerland , Germany , Canada , Australia , 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 Gene Arcy'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 Gene Arcy.
Note: The EIR and 483 documents are sold separately.
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