Laurie Haxel InspectorProfile

This FDA InspectorProfile is a report of relevant audit-related information on Laurie Haxel, 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 2014 and lists Laurie Haxel's inspections in 8 countries: United States, Germany, Finland, Canada, United Kingdom, Ukraine, Italy, and Spain.

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 Laurie Haxel'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 Laurie Haxel.

Product details

• Laurie Haxel'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) Laurie Haxel has conducted including:
  • Company, site inspected, duration of inspection
  • Co-inspectors Linda Mattingly, Margaret Torres-Vazquez, Merelynn Rhoten, Tania Hall, Linda Hoover, 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.