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Mark Nakano FDA Investigator Profile

Redica Systems FDA Investigator Profile
(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

Mark Nakano Details

This InspectorProfile report is updated through and lists Mark Nakano's inspections in 2 countries: United States, and Guatemala. They recently co-inspected with Marissa Chan, Thomas Adjabeng, Steven Chiu, Nympha Florendo, and Jeanne Young.

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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