This InspectorProfile is a report of relevant audit-related information on Marlene Davis, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Biologics.
This InspectorProfile report is updated through and lists Marlene Davis's 126 inspections in 3 countries: United States, Italy, and Spain.
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 Marlene Davis'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 Marlene Davis.
Note: The EIR and 483 documents are sold separately.Add To Cart3 of Marlene's 483s Available Now.