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Hi, Frances. If we’re going to do the research for a client, we need a way to download the list of Firms (Name, FEI Number, Address, etc) or we need to ask enough questions of the customer to start a process that allows us to manually find the target firm(s) and manually run the required queries.

Here’s my first stab at a process:

  • A client logs into our web portal.
  • The client completes a form that asks for:
    • Company Name (Bimbo).
    • Industry (in the event that Bimbo makes bread and Bimbo makes bicycles).
    • Region (Bimbo has bakeries all over the world).
    • Nature of the query (Warning Letters, Import Alerts, Recalls, etc.)
  • Once we have the form in-hand, we use the appropriate FDA query forms to run the queries and catalog the results.
  • We format the results and send them to the client.

A prototype form can be found here: https://qes-fda.qualityessentialssuite.com/new-query/

Using the info from our form, we query the FDA for Firm Identities here: https://datadashboard.fda.gov/ora/fd/fser.htm

After paring down the results, we run additional FDA queries for reported data on a specific form here:https://datadashboard.fda.gov/ora/firmprofile.htm?FEIs=3004655912&/identity/3004655912