Jane Chen InspectorProfile

This FDA InspectorProfile is a report of relevant audit-related information on Jane Chen, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Foods & Cosmetics.

Product Description

This InspectorProfile report is updated through Dec 2017 and lists Jane Chen's inspections in 42 countries: Bulgaria, Norway, United States, Korea, Republic Of (South), Korea (the Republic of), Peru, Italy, Canada, Taiwan (Province of China), Taiwan, India, China, Jamaica, Spain, Costa Rica, Belgium, Germany, Australia, Japan, Dominican Republic (the), Thailand, Dominican Republic, Poland, Ecuador, Argentina, Portugal, Sri Lanka, Brazil, Vietnam, Indonesia, Mexico, Bahamas, Guatemala, France, Chile, Ireland, Ghana, Lithuania, United Kingdom, Philippines, Netherlands, and South Africa.

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 Jane Chen'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 Jane Chen.

Product details

• Jane Chen'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) Jane Chen has conducted including:
  • Company, site inspected, duration of inspection
  • Co-inspectors Brant Schroeder, Samuel Rudnitsky, Amy Kim, Kwong Lee, Douglas Ng, 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.