This InspectorProfile is a report of relevant audit-related information on James Montero, 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 Montero's 157 inspections in 15 countries: United States, Costa Rica, Argentina, Brazil, France, Switzerland, United Kingdom, China, Japan, Taiwan, Italy, Australia, Germany, Sweden, and Poland.
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 Montero'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 Montero.
Note: The EIR and 483 documents are sold separately.Add To Cart25 of James's 483s Available Now.