(image from former FDA Investigator Peter Baker's profile in Redica Systems)
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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
James Montero Details
This InspectorProfile report is updated through and lists James Montero's inspections in 23 countries: United States, Costa Rica, Argentina, Brazil, France, Switzerland, United Kingdom, China, Japan, Taiwan, Italy, Australia, Germany, Sweden, Finland, Czech Republic, Poland, Singapore, Indonesia, Romania, Bulgaria, Netherlands, and Hungary. They recently co-inspected with Rebecca Stephany, Paul Kawamoto, Juanj Wu, Juanj Wu, and Constance Dobbins.
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.
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