Louis An InspectorProfile


This InspectorProfile is a report of relevant audit-related information on Louis An, 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 Louis An's 3 inspections in 1 countries: 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 Louis An'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 Louis An.

Example Report

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

Product details

  • Louis An'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) Louis An has conducted including:
    • Company, site inspected, duration of inspection
    • Co-inspectors like Helen Ricalde FDA, Samantha Bradley FDA, year of last co-inspection, number of co-inspections
    • If a 483 issued, and whether or not it resulted in a warning letter.

Note: The EIR and 483 documents are sold separately.

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