FDA Investigator Profile

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FDA Investigator Profiles from Redica Systems, the parent company of FDAzilla, include the following data points (and more):

• Total number of inspections
• 483 issuance rate
• Resulting Warning Letter rate (FDA Investigators don't directly issue Warning Letters themselves, but the agency decides whether or not to issue a Warning Letter based on the Investigator's report.)
• Trends of the Investigator's last 10 inspections
• Top 5 cited categories

Details

This InspectorProfile report is updated through and lists 's inspections in 0 countries: . They recently co-inspected with .

Inspector Profiles Are Just the Tip of the Iceberg

Becoming a Redica Systems customer grants you access to not only unlimited access to profiles like the one above for every current and former FDA Investigator, but also:

• Inspection Intelligence
  • Pre-Approval Inspection (PAI) trends
  • The ability to filter nearly any FDA enforcement action by GxP labels like GMP, GCP, etc.
  • Latest 483s: see what the trends are across all FDA Investigators
  • CFR Heatmap: Citations aggregated by Subpart by Year.
• Supplier Intelligence
  • Full inspection histories for your suppliers down to the specific site level
  • All of the functionality mentioned above but isolated to just your suppliers
• Regulatory Intelligence
  • Zero in on the trends for a specific agency/regulator (ex. FDA, MHRA, EMA, Health Canada)
  • All the latest "Signals" from agencies around the world, segmented by Country, Type (ex. Guidance, Decree...), Category (ex. Rules/Regulations/Guidance, News, Reports...), Theme (ex. Cell and Gene Therapy, AI...), and more.

Fill out the form on the right to get in touch with Redica Systems.