This FDA InspectorProfile is a report of relevant audit-related information on Burnell Henry, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Biologics.
This InspectorProfile report is updated through and lists Burnell Henry's inspections in 19 countries: United States, United Kingdom, Italy, Belgium, Netherlands, Portugal, Ireland, Japan, China, Denmark, Austria, Canada, Switzerland, France, Spain, Ukraine, Israel, Germany, and Singapore.
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 Burnell Henry'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 Burnell Henry.
Note: The EIR and 483 documents are sold separately.