KPL

Kwong Lee InspectorProfile

$795.00

This 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 428 inspections in 11 countries: United States, Malaysia, Switzerland, Taiwan, United Kingdom, China, Australia, Japan, Thailand, Korea (the Republic of), and Italy.

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.

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

Example Report

Kwong Lee FDA InspectorProfile Overview Example
Kwong Lee FDA InspectorProfile Metrics Example
Kwong Lee FDA InspectorProfile Citations Example
Kwong Lee FDA InspectorProfile Inspections List
Add To Cart22 of Lee 483s in stock

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.

Add To Cart22 of Kwong's 483s Available Now.