This FDA InspectorProfile is a report of relevant audit-related information on James Beaulieu, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Medical Devices & Rad Health.
This InspectorProfile report is updated through and lists James Beaulieu's inspections in 21 countries: United States, Ireland, Germany, Belgium, Switzerland, Costa Rica, Mexico, China, Italy, France, Korea (the Republic of), Sweden, New Zealand, Japan, United Kingdom, Finland, Taiwan, Korea, Republic Of (South), Bulgaria, Czech Republic, and Canada.
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 James Beaulieu'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 James Beaulieu.
Note: The EIR and 483 documents are sold separately.