Walden Lee InspectorProfile

This FDA InspectorProfile is a report of relevant audit-related information on Walden Lee, 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 Aug 2021 and lists Walden Lee's inspections in 15 countries: United States, New Zealand, Singapore, Finland, United Kingdom, India, Canada, Germany, China, Ireland, Italy, France, Switzerland, Israel, and Australia.

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 Walden Lee'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 Walden Lee.

Product details

• Walden Lee'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) Walden Lee has conducted including:
  • Company, site inspected, duration of inspection
  • Co-inspectors Bryan Galvez, Nayan Patel, Teresa Navas, Saundrea Munroe, Cynthia Jim, 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.