This FDA InspectorProfile is a report of relevant audit-related information on Dorothy Lee, 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 Dorothy Lee's inspections in 23 countries: United States, Germany, Denmark, France, Switzerland, Ireland, Belgium, Italy, Netherlands, Spain, Australia, Japan, Korea, Republic Of (South), Estonia, Hungary, Austria, Turkey, United Kingdom, Israel, Singapore, Korea (the Republic of), Slovenia, and Sweden.
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 Dorothy Lee'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 Dorothy Lee.
Note: The EIR and 483 documents are sold separately.