This FDA InspectorProfile is a report of relevant audit-related information on James Fleckenstein, 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 Fleckenstein's inspections in 26 countries: United States, France, Italy, Norway, Denmark, Belgium, United Kingdom, Netherlands, Mexico, Russia, Australia, China, Poland, Canada, Argentina, Latvia, Turkey, Czech Republic, India, South Africa, Romania, Bulgaria, Ukraine, Germany, Japan, 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 James Fleckenstein'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 Fleckenstein.
Note: The EIR and 483 documents are sold separately.