Mizanne Lewis InspectorProfile

This FDA 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 May 2019 and lists Mizanne Lewis's inspections in 14 countries: United States, France, Italy, Serbia, Hungary, Israel, Latvia, Poland, Ethiopia, Russia, Czech Republic, Belgium, Germany, and Japan.

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.

Example Report

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

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:
  • Company, site inspected, duration of inspection
  • Co-inspectors Ivan Reyes, Thai Truong, Lura Baquero, Amy Kim, Dianiris Ayala, 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.