Denise Burosh InspectorProfile

$795.00

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.

Product Description

This InspectorProfile report is updated through Sep 26 2019 and lists Denise Burosh's 502 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.

Add InspectorProfile + Last 5 x 483 - $995

Add InspectorProfile - $795

Add Last 5 x 483 - $595

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.

Example Report

Denise Burosh FDA InspectorProfile Overview Example

Denise Burosh FDA InspectorProfile Metrics Example

Denise Burosh FDA InspectorProfile Citations Example

Denise Burosh FDA InspectorProfile Inspections List

Add To Cart 34 of Burosh 483s in stock

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 like Debra Boyd Seale FDA, Shalonda Clifford FDA, Nicole Victoria FDA, Makini Cobourne-Duval FDA, Himanshu Gupta FDA, 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.

Add To Cart 34 of Denise's 483s Available Now.