This FDA InspectorProfile is a report of relevant audit-related information on Bo Chi, 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 Bo Chi's inspections in 13 countries: United States, Germany, United Kingdom, Singapore, Switzerland, Ireland, Korea (the Republic of), Slovenia, Spain, China, Japan, Denmark, and Taiwan.
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 Bo Chi'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 Bo Chi.
Note: The EIR and 483 documents are sold separately.