Vien Le InspectorProfile


This InspectorProfile is a report of relevant audit-related information on Vien Le, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Biologics.

Product Description

This InspectorProfile report is updated through and lists Vien Le's 100 inspections in 6 countries: United States, Japan, Korea (the Republic of), Belgium, United Kingdom, and Vietnam.

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 Vien Le'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 Vien Le.

Example Report

Vien Le FDA InspectorProfile Overview Example
Vien Le FDA InspectorProfile Metrics Example
Vien Le FDA InspectorProfile Citations Example
Vien Le FDA InspectorProfile Inspections List
Add To Cart3 of Le 483s in stock

Product details

  • Vien Le'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) Vien Le has conducted including:

Note: The EIR and 483 documents are sold separately.

Add To Cart3 of Vien's 483s Available Now.