This 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.
This InspectorProfile report is updated through and lists Denise Burosh's 511 inspections in 22 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, and China.
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.
Below is an example of what a FDAzilla InspectorProfile report contains; This is not the actual data for Denise Burosh.
Note: The EIR and 483 documents are sold separately.Add To Cart37 of Denise's 483s Available Now.