FDA 483 data is just the tip of the iceberg
FDAzilla Store by Redica Cart
AboutBlogFDA EmployeeOver 40,000+ FDA inspection documents: 483s, EIRs, 483Rs
inspectorprofile icon

MDSAP harperd InspectorProfile

$1,493 - Available for instant download

This FDA InspectorProfile is a report of relevant audit-related information on MDSAP harperd, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Medical Devices & Rad Health.

Product Description

This InspectorProfile report is updated through and lists MDSAP harperd's inspections in 30 countries: United States, Ireland, Canada, Switzerland, Germany, Korea (the Republic of), Costa Rica, Australia, China, United Kingdom, Singapore, Taiwan, Italy, Spain, Sweden, Finland, Malaysia, India, Israel, Belgium, New Zealand, Honduras, Netherlands, Japan, Mexico, Georgia, France, Denmark, Norway, and Austria.

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 MDSAP harperd'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 MDSAP harperd.

FDA InspectorProfile Overview Example
FDA InspectorProfile Metrics Example
FDA InspectorProfile Citations Example
FDA InspectorProfile Inspections List

Product details

  • MDSAP harperd'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) MDSAP harperd has conducted including:
    • Company, site inspected, duration of inspection
    • Co-inspectors MDSAP WilliamsA, MDSAP GonzlezK, MSDAP GonzlezK, 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.