Bo Chi InspectorProfile

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.

Product Description

This InspectorProfile report is updated through Mar 2020 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.

Example Report

Below is an example of what a FDAzilla InspectorProfile report contains; This is not the actual data for Bo Chi.

Product details

• Bo Chi's metrics:
  • 483 issue rate, total inspections, total 483s
  • Most common citations (based on CFR), CFR description, and citation frequency
  • Total inspections, total 483s
  • Longest / shortest inspection in duration - all time, last year
  • Total warning letters
• Inspection details for each inspection (since 2000) Bo Chi has conducted including:
  • Company, site inspected, duration of inspection
  • Co-inspectors Scott Golladay, Wayne Seifert, Jazmine Still, Anita Narula, Maxwell Van Tassell, year of last co-inspection, number of co-inspections
  • If a 483 issued, and whether or not it resulted in a warning letter.

Note: The EIR and 483 documents are sold separately.