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FDA Data MCP

by io.github.medley
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Clean FDA regulatory data: company resolution, facilities, recalls, inspections, approvals.

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Status
Unhealthy
Uptime
76.1% over 62 days
OAuth
Requires browser extension
Last Tested
Transport
Streamable HTTP
URL

TDQS

A3.8/5.0

Scored across 46 tools

Disambiguation2/5

Multiple pairs/triples of tools target the same underlying dataset with only subtle differences (e.g., fda_device_udi vs fda_device_udi_lookup; fda_company_full vs fda_lookup_company vs fda_manufacturing_risk_summary; fda_search_enforcement vs fda_ires_enforcement vs fda_device_recalls). While descriptions include 'Related:' pointers, an agent can still easily misselect.

Naming Consistency4/5

All tools share a consistent fda_ prefix and snake_case. Verb usage varies (search_, get_, lookup_, resolve_, suggest_) and some are noun phrases (fda_company_full, fda_device_udi), but the overall pattern is predictable and readable.

Tool Count2/5

46 tools far exceeds the recommended 3–15 range. The FDA domain is broad, but the set is bloated with overlapping tools (e.g., multiple UDI, recall, and company profile tools) that could be consolidated, making it heavy and harder to navigate.

Completeness4/5

The surface covers a remarkable breadth of FDA datasets—drugs, devices, foods, cosmetics, tobacco, veterinary, inspections, recalls, warning letters, import alerts/refusals, debarments, shortages, and more. Minor gaps remain (e.g., food/cosmetic facility registration, advisory committee data), but core regulatory workflows are well supported.

Tool Schema Changelog

Recent tool additions, removals, and schema changes observed during successful MCP inspections.

  1. 2 tool updates
    • Removedfda_link_subsidiaries
    • Removedfda_save_aliases
  2. 5 tool updates
    • Changedfda_citations7 fields changed
      • changedInput schema / properties / act_cfr_number / description
        Previous value: -"CFR number (exact match)"New value: +"CFR section, section-anchored prefix match (e.g. '21 CFR 211.68' or '211.68' matches 211.68, 211.68(a), 211.68(b) but not 211.680 or 211.6)"
      • addedInput schema / properties / classification
        Added value: +{
+  "description": "Parent inspection classification (NAI=No Action Indicated, VAI=Voluntary Action Indicated, OAI=Official Action Indicated)",
+  "enum": [
+    "NAI",
+    "VAI",
+    "OAI"
+  ],
+  "type": "string"
+}
      • addedInput schema / properties / date_from
        Added value: +{
+  "description": "Start date for inspection_end_date range (YYYY-MM-DD)",
+  "pattern": "^\\d{4}-\\d{2}-\\d{2}$",
+  "type": "string"
+}
      • addedInput schema / properties / date_to
        Added value: +{
+  "description": "End date for inspection_end_date range (YYYY-MM-DD)",
+  "pattern": "^\\d{4}-\\d{2}-\\d{2}$",
+  "type": "string"
+}
      • addedInput schema / properties / fiscal_year
        Added value: +{
+  "description": "Fiscal year of the inspection",
+  "maximum": 2100,
+  "minimum": 2000,
+  "type": "integer"
+}
      • addedInput schema / properties / offset
        Added value: +{
+  "default": 0,
+  "description": "Result offset for pagination",
+  "maximum": 9007199254740991,
+  "minimum": 0,
+  "type": "integer"
+}
      • addedInput schema / properties / program_area
        Added value: +{
+  "description": "Program area (partial match, e.g. Drugs, Devices, Foods)",
+  "maxLength": 200,
+  "type": "string"
+}
    • Changedfda_company_compliance_timeline1 field changed
      • addedInput schema / properties / verbose
        Added value: +{
+  "default": false,
+  "description": "When false (default), suppress the inline alias dump and collapse per-dataset data_freshness to a single top-level as_of. Set true for the full block.",
+  "type": "boolean"
+}
    • Changedfda_manufacturing_risk_summary1 field changed
      • addedInput schema / properties / verbose
        Added value: +{
+  "default": false,
+  "description": "When false (default), suppress the inline alias dump and collapse per-dataset data_freshness to a single top-level as_of. Set true for the full block.",
+  "type": "boolean"
+}
    • Changedfda_recall_facility_trace4 fields changed
      • addedInput schema / properties / firm
        Added value: +{
+  "description": "Recalling firm name (fuzzy). Convenience path: resolves the best-matching recall when recall_number is omitted.",
+  "maxLength": 500,
+  "type": "string"
+}
      • addedInput schema / properties / product
        Added value: +{
+  "description": "Optional product keyword to narrow firm-based resolution (matches product_description).",
+  "maxLength": 500,
+  "type": "string"
+}
      • changedInput schema / properties / recall_number / description
        Previous value: -"Recall number"New value: +"Recall number (preferred). If omitted, provide firm to auto-resolve."
      • removedInput schema / required
        Removed value: -[
-  "recall_number"
-]
    • Changedfda_search_warning_letters4 fields changed
      • addedInput schema / properties / dedupe
        Added value: +{
+  "default": false,
+  "description": "Collapse letters sharing a MARCS-CMS case number to one canonical row (recommended for prospecting)",
+  "type": "boolean"
+}
      • addedInput schema / properties / letter_category
        Added value: +{
+  "description": "Heuristic category derived from issuing_office/subject/product_type",
+  "enum": [
+    "CGMP-manufacturing",
+    "BIMO",
+    "listing",
+    "OPDP/promotion",
+    "503B/compounding",
+    "import"
+  ],
+  "type": "string"
+}
      • addedInput schema / properties / status
        Added value: +{
+  "description": "Derived status: closed (has closeout date), responded (has response date), or open",
+  "enum": [
+    "open",
+    "responded",
+    "closed"
+  ],
+  "type": "string"
+}
      • addedInput schema / properties / violation_theme
        Added value: +{
+  "description": "Heuristic violation theme derived from subject and letter body text",
+  "enum": [
+    "cgmp_subsystem",
+    "data_integrity",
+    "validation",
+    "bimo",
+    "listing",
+    "promotion"
+  ],
+  "type": "string"
+}
  3. 2 tool updates
    • Addedfda_company_compliance_timeline
    • Addedfda_facility_dossier
  4. 2 tool updates
    • Addedfda_link_subsidiaries
    • Addedfda_search_family_facilities
  5. 44 tool updates
    • First observedfda_bpdr_summary
    • First observedfda_citations
    • First observedfda_clinical_result_letters
    • First observedfda_company_full
    • First observedfda_compliance_actions
    • First observedfda_consumer_events
    • First observedfda_device_class
    • First observedfda_device_recalls
    • First observedfda_device_supply_status
    • First observedfda_device_udi
    • First observedfda_device_udi_lookup
    • First observedfda_drug_labels
    • First observedfda_drug_shortages
    • First observedfda_facility_products
    • First observedfda_get_facility
    • First observedfda_import_refusals
    • First observedfda_inspection_observation_summary
    • First observedfda_inspections
    • First observedfda_ires_enforcement
    • First observedfda_lookup_company
    • First observedfda_manufacturing_risk_summary
    • First observedfda_product_code_lookup
    • First observedfda_recall_facility_trace
    • First observedfda_resolve_company
    • First observedfda_save_aliases
    • First observedfda_search_510k
    • First observedfda_search_aphis
    • First observedfda_search_by_product
    • First observedfda_search_debarments
    • First observedfda_search_drugs
    • First observedfda_search_enforcement
    • First observedfda_search_facilities
    • First observedfda_search_import_alerts
    • First observedfda_search_ndc
    • First observedfda_search_nsde
    • First observedfda_search_oii_records
    • First observedfda_search_opdp_untitled_letters
    • First observedfda_search_pma
    • First observedfda_search_recall_text
    • First observedfda_search_warning_letters
    • First observedfda_substance_lookup
    • First observedfda_suggest_subsidiaries
    • First observedfda_tobacco_problems
    • First observedfda_vet_events

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