Xiaohui Shen InspectorProfile


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

Product Description

This InspectorProfile report is updated through and lists Xiaohui Shen's 4 inspections in 3 countries: Germany, India, and United States.

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 Xiaohui Shen'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 Xiaohui Shen.

Example Report

Xiaohui Shen FDA InspectorProfile Overview Example
Xiaohui Shen FDA InspectorProfile Metrics Example
Xiaohui Shen FDA InspectorProfile Citations Example
Xiaohui Shen FDA InspectorProfile Inspections List
Add To Cart2 of Shen 483s in stock

Product details

  • Xiaohui Shen'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) Xiaohui Shen has conducted including:

Note: The EIR and 483 documents are sold separately.

Add To Cart2 of Xiaohui's 483s Available Now.