This InspectorProfile is a report of relevant audit-related information on Sharon Gundersen, 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 Sharon Gundersen's 108 inspections in 7 countries: United States, Germany, Netherlands, Austria, United Kingdom, France, and Finland.
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 Sharon Gundersen'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 Sharon Gundersen.
Note: The EIR and 483 documents are sold separately.Add To Cart26 of Sharon's 483s Available Now.