This FDA InspectorProfile is a report of relevant audit-related information on Marie Buen-Bigornia, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Foods & Cosmetics.
This InspectorProfile report is updated through and lists Marie Buen-Bigornia's inspections in 7 countries: United States, Philippines, Taiwan, Vietnam, Italy, France, and India.
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 Marie Buen-Bigornia'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 Marie Buen-Bigornia.
Note: The EIR and 483 documents are sold separately.