RegDataLab provides an MCP server that exposes 48 tools to query 37 FDA regulatory datasets, including facility inspections, warning letters, recalls, import alerts, and drug shortages, enabling AI agents to perform regulatory intelligence and compliance diligence.
- Operator: Wasatch Crest Holdings LLC
- Endpoint: https://www.regdatalab.com/mcp
- Transport: streamable-http
- Sign-in: OAuth sign-in
- Category: Data and analytics
- Use cases: Track a company's enforcement posture across inspections and warning letters; Assess acquisition targets by pulling facility histories and recall exposure; Vet contract manufacturers against real inspection records and Form 483 citations
- Tools: fda_lookup_company, fda_search_facilities, fda_search_family_facilities, fda_get_facility, fda_facility_dossier, fda_facility_products, fda_search_enforcement, fda_search_recall_text, fda_resolve_company, fda_suggest_subsidiaries, fda_manufacturing_risk_summary, fda_company_compliance_timeline, fda_search_aphis, fda_search_510k, fda_search_pma, fda_device_class, fda_product_code_lookup, fda_search_drugs, fda_search_ndc, fda_search_by_product, fda_recall_facility_trace, fda_company_full, fda_inspections, fda_citations, fda_compliance_actions, fda_search_warning_letters, fda_search_opdp_untitled_letters, fda_search_oii_records, fda_search_debarments, fda_search_import_alerts, fda_bpdr_summary, fda_device_supply_status, fda_inspection_observation_summary, fda_import_refusals, fda_ires_enforcement, fda_drug_shortages, fda_device_recalls, fda_consumer_events, fda_vet_events, fda_tobacco_problems, fda_substance_lookup, fda_search_nsde, fda_clinical_result_letters, fda_drug_labels, fda_device_udi, fda_device_udi_lookup
- Documentation: https://www.regdatalab.com/docs
- Directory listing: https://koskamo.com/explore/regdatalab-mcp
- Also known as: RegDataLab MCP MCP; regdatalab-mcp