This InspectorProfile is a report of relevant audit-related information on Gerard De Leon, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Foods & Cosmetics.
This InspectorProfile report is updated through and lists Gerard De Leon's 107 inspections in 4 countries: United States, Sweden, Japan, and Germany.
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 Gerard De Leon'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 Gerard De Leon.
Note: The EIR and 483 documents are sold separately.Add To Cart13 of Gerard's 483s Available Now.