This FDA InspectorProfile is a report of relevant audit-related information on Byungja Marciante, 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 Byungja Marciante's inspections in 23 countries: United States, Korea, Republic Of (South), Australia, Japan, Korea (the Republic of), New Zealand, Germany, Austria, Ireland, Thailand, Czech Republic, Hong Kong SAR, United Kingdom, Italy, China, Romania, Denmark, Switzerland, Greece, Serbia, Sweden, Brazil, and Russia.
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 Byungja Marciante'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 Byungja Marciante.
Note: The EIR and 483 documents are sold separately.