MEL

Mizanne Lewis InspectorProfile

$795.00

This InspectorProfile is a report of relevant audit-related information on Mizanne Lewis, 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 Mizanne Lewis's 219 inspections in 13 countries: United States, France, Italy, Serbia, Hungary, Israel, Latvia, Poland, Ethiopia, Russia, Czech Republic, Germany, and Belgium.

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 Mizanne Lewis'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 Mizanne Lewis.

Example Report

Mizanne Lewis FDA InspectorProfile Overview Example
Mizanne Lewis FDA InspectorProfile Metrics Example
Mizanne Lewis FDA InspectorProfile Citations Example
Mizanne Lewis FDA InspectorProfile Inspections List
Add To Cart7 of Lewis 483s in stock

Product details

  • Mizanne Lewis'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) Mizanne Lewis has conducted including:

Note: The EIR and 483 documents are sold separately.

Add To Cart7 of Mizanne's 483s Available Now.