JRM

James Montero InspectorProfile

$795.00

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.

Product Description

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.

Example Report

James Montero FDA InspectorProfile Overview Example
James Montero FDA InspectorProfile Metrics Example
James Montero FDA InspectorProfile Citations Example
James Montero FDA InspectorProfile Inspections List
Add To Cart25 of Montero 483s in stock

Product details

  • James Montero's metrics:
    • 483 issue rate, total inspections, total 483s
    • Most common citations (based on CFR), CFR description, and citation frequency
    • Total inspections, total 483s
    • Longest / shortest inspection in duration - all time, last year
    • Total warning letters
  • Inspection details for each inspection (since 2000) James Montero has conducted including:

Note: The EIR and 483 documents are sold separately.

Add To Cart25 of James's 483s Available Now.