FDA 483 data is just the tip of the iceberg
AboutBlogFDA EmployeeOver 40,000+ FDA inspection documents: 483s, EIRs, 483Rs
inspectorprofile icon

Kwong Lee InspectorProfile

$795 - Available for instant download

This FDA InspectorProfile is a report of relevant audit-related information on Kwong Lee, 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 Kwong Lee's inspections in 12 countries: United States, Malaysia, Switzerland, Taiwan, United Kingdom, China, Australia, Japan, Korea (the Republic of), Thailand, Italy, and Singapore.

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 Kwong Lee's inspection information so that you can mitigate investigator-related risks.

Example Report

Below is an example of what a FDAzilla InspectorProfile report contains; This is not the actual data for Kwong Lee.

FDA InspectorProfile Overview Example
FDA InspectorProfile Metrics Example
FDA InspectorProfile Citations Example
FDA InspectorProfile Inspections List

Product details

  • Kwong Lee'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) Kwong Lee has conducted including:

Note: The EIR and 483 documents are sold separately.