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Sara Rothman InspectorProfile

$995

This InspectorProfile is a report of relevant audit-related information on Sara Rothman, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Human Drugs.

Product Description

This InspectorProfile report is updated through and lists Sara Rothman's 1 inspections in 1 countries: and United States.

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 Sara Rothman'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 Sara Rothman.

Example Report

Sara Rothman FDA InspectorProfile Overview Example
Sara Rothman FDA InspectorProfile Metrics Example
Sara Rothman FDA InspectorProfile Citations Example
Sara Rothman FDA InspectorProfile Inspections List
Add To Cart1 of Rothman 483s in stock

Product details

  • Sara Rothman'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) Sara Rothman has conducted including:
    • Company, site inspected, duration of inspection
    • Co-inspectors like Scott Ballard FDA, Camerson Moore 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 Cart1 of Sara's 483s Available Now.