Denise Burosh InspectorProfile

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

Product Description

This InspectorProfile report is updated through Oct 2022 and lists Denise Burosh's inspections in 23 countries: United States, Cyprus, Germany, Poland, Spain, Canada, Philippines, Thailand, India, Georgia, Serbia, Singapore, Netherlands, South Africa, Honduras, France, Czech Republic, Korea (the Republic of), Brazil, Argentina, Taiwan, China, and Greece.

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 Denise Burosh'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 Denise Burosh.

Product details

• Denise Burosh'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) Denise Burosh has conducted including:
  • Company, site inspected, duration of inspection
  • Co-inspectors Xiaohan Cai, Eric Myskowski, Camille Brown, Kara Scheibner, Debra Boyd Seale, 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.