HBR

Helen Ricalde InspectorProfile

$795.00

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

Product Description

This InspectorProfile report is updated through and lists Helen Ricalde's 219 inspections in 22 countries: United States, France, Germany, Italy, Spain, Belgium, Korea (the Republic of), Denmark, United Kingdom, Sweden, Austria, Ireland, Australia, Switzerland, Singapore, Mexico, Peru, India, Malta, Canada, Norway, and Netherlands.

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 Helen Ricalde'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 Helen Ricalde.

Example Report

Helen Ricalde FDA InspectorProfile Overview Example
Helen Ricalde FDA InspectorProfile Metrics Example
Helen Ricalde FDA InspectorProfile Citations Example
Helen Ricalde FDA InspectorProfile Inspections List
Add To Cart22 of Ricalde 483s in stock

Product details

  • Helen Ricalde'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) Helen Ricalde has conducted including:

Note: The EIR and 483 documents are sold separately.

Add To Cart22 of Helen's 483s Available Now.