Paula Bretz InspectorProfile

This FDA InspectorProfile is a report of relevant audit-related information on Paula Bretz, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Biologics.

Product Description

This InspectorProfile report is updated through Nov 2014 and lists Paula Bretz's inspections in 14 countries: United States, Italy, Hungary, United Kingdom, Germany, India, Russia, China, France, Latvia, Brazil, Malta, Panama, and Canada.

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 Paula Bretz'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 Paula Bretz.

Product details

• Paula Bretz'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) Paula Bretz has conducted including:
  • Company, site inspected, duration of inspection
  • Co-inspectors Brian Palermo, Barbara Wright, Jonathan Chapman, Brooke Higgins, Dianne Milazzo, 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.