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Single-Company Monitoring Playbook

RegDataLab Team10 min read

This is a practical playbook for monitoring one company using FDA Data MCP. It is designed to be operational: run these calls daily/weekly and store outputs with provenance.

1) Resolve company + aliases

mcporter call fda-data.fda_company_full company='Pfizer' --output json

2) Facilities (FEI list)

  • Extract FEIs from facilities.results.
  • Drill down: fda_get_facility per FEI as needed.

3) Recalls / enforcement

mcporter call fda-data.fda_search_enforcement company='Pfizer' --output json

4) Device submissions

mcporter call fda-data.fda_search_510k company='Pfizer' --output json
mcporter call fda-data.fda_search_pma company='Pfizer' --output json

5) Drugs + NDC + labels

mcporter call fda-data.fda_search_drugs company='Pfizer' --output json
mcporter call fda-data.fda_search_ndc labeler='Pfizer' --output json
mcporter call fda-data.fda_drug_labels product='Chantix' --output json

6) Dashboard feeds

mcporter call fda-data.fda_inspections company_name='Pfizer' --output json
mcporter call fda-data.fda_compliance_actions company_name='Pfizer' --output json

7) Provenance + audit trail

  • Store tool name + parameters with each result set.
  • Store timestamps and pagination metadata.
  • Avoid interpretations not present in MCP output.

Fact-check checklist

  • MCP-only fields and definitions.
  • No external regulatory claims.
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