fda-mcp-server 0.0.3 → 0.0.7

package/dist/index.js

@@ -2,213 +2,62 @@
 /**
  * FDA MCP Server
  *
- * MCP server exposing FDA Warning Letters, Form 483 Inspections,
- * and Enforcement/Recall data as queryable tools.
+ * Tools for querying FDA enforcement, adverse event, and compliance data.
  *
  * Data sources:
- * - FDA.gov Warning Letters (Drupal/Solr DataTables)
- * - FDA.gov FOIA 483 Inspection Observations
- * - openFDA Enforcement (Recalls) API
+ * - openFDA Enforcement/Recalls API (live)
+ * - openFDA Device Adverse Events / MAUDE (live)
+ * - fda-csa-data enriched dataset (warning letters, 483s, citations, CSA analysis)
  */
 import { McpServer } from "@modelcontextprotocol/sdk/server/mcp.js";
 import { StdioServerTransport } from "@modelcontextprotocol/sdk/server/stdio.js";
 import { z } from "zod";
-import { searchWarningLetters, searchInspections, searchEnforcement, get483XlsxUrls, } from "./fda-client.js";
-import { isEnrichedAvailable, validateApiKey, testConnection, csaRiskAssessment, citationAnalysis, supplierQualification, } from "./db.js";
+import { searchEnforcement, searchDeviceEvents } from "./fda-client.js";
+import { isEnrichedAvailable, validateApiKey, testConnection, csaRiskAssessment, citationAnalysis, supplierQualification, companyEnrichedProfile, } from "./db.js";
 const server = new McpServer({
     name: "fda-mcp-server",
     version: "1.0.0",
 });
-// ─── Tool: search_warning_letters ────────────────────────────────────────────
-server.tool("search_warning_letters", "Search FDA warning letters by company name, keyword, issuing office, or date range. Returns letter metadata including subject, issuing office, dates, and excerpts.", {
-    search: z
-        .string()
-        .optional()
-        .describe("Search term (company name, keyword, CFR citation, etc.)"),
-    issuing_office: z
-        .string()
-        .optional()
-        .describe("Filter by issuing office (e.g., 'CDRH', 'CDER', 'CBER', 'ORA')"),
-    date_from: z
-        .string()
-        .optional()
-        .describe("Start date for issue date filter (YYYY-MM-DD)"),
-    date_to: z
-        .string()
-        .optional()
-        .describe("End date for issue date filter (YYYY-MM-DD)"),
-    limit: z
-        .number()
-        .min(1)
-        .max(100)
-        .optional()
-        .describe("Max results to return (default 25, max 100)"),
-    offset: z
-        .number()
-        .min(0)
-        .optional()
-        .describe("Pagination offset (default 0)"),
-}, async (params) => {
-    try {
-        const result = await searchWarningLetters(params);
-        if (result.letters.length === 0) {
-            return {
-                content: [
-                    {
-                        type: "text",
-                        text: `No warning letters found matching your criteria.`,
-                    },
-                ],
-            };
-        }
-        const summary = [
-            `## FDA Warning Letters`,
-            `**Total results:** ${result.total}`,
-            `**Showing:** ${result.letters.length} (offset ${params.offset ?? 0})`,
-            ``,
-        ];
-        for (const letter of result.letters) {
-            summary.push(`### ${letter.company_name}`);
-            summary.push(`- **Subject:** ${letter.subject}`);
-            summary.push(`- **Issue Date:** ${letter.issue_date}`);
-            summary.push(`- **Issuing Office:** ${letter.issuing_office}`);
-            if (letter.url)
-                summary.push(`- **URL:** ${letter.url}`);
-            if (letter.excerpt) {
-                const excerpt = letter.excerpt.length > 300
-                    ? letter.excerpt.substring(0, 300) + "..."
-                    : letter.excerpt;
-                summary.push(`- **Excerpt:** ${excerpt}`);
-            }
-            summary.push(``);
-        }
-        return {
-            content: [{ type: "text", text: summary.join("\n") }],
-        };
-    }
-    catch (error) {
+// ─── Helper: gate enriched tools ─────────────────────────────────────────────
+function enrichedGate() {
+    if (!isEnrichedAvailable()) {
         return {
+            ok: false,
             content: [
                 {
                     type: "text",
-                    text: `Error searching warning letters: ${error instanceof Error ? error.message : String(error)}`,
+                    text: "This tool requires the enriched fda-csa-data dataset. Set DATABASE_URL to your PostgreSQL instance.\n\nSee: https://github.com/jasencarroll/fda-csa-data",
                 },
             ],
-            isError: true,
         };
     }
-});
-// ─── Tool: search_483_inspections ────────────────────────────────────────────
-server.tool("search_483_inspections", "Search FDA Form 483 inspection observations. Returns firm name, FEI number, location, inspection date, classification, center, and posted citations.", {
-    firm_name: z
-        .string()
-        .optional()
-        .describe("Search by firm/company name"),
-    state: z
-        .string()
-        .optional()
-        .describe("Filter by US state (e.g., 'PA', 'CA', 'NJ')"),
-    center: z
-        .string()
-        .optional()
-        .describe("Filter by FDA center (e.g., 'CDRH', 'CDER', 'CBER')"),
-    project_area: z
-        .string()
-        .optional()
-        .describe("Filter by project area (e.g., 'Drugs', 'Devices', 'Biologics')"),
-    date_from: z
-        .string()
-        .optional()
-        .describe("Start date for inspection end date filter (YYYY-MM-DD)"),
-    date_to: z
-        .string()
-        .optional()
-        .describe("End date for inspection end date filter (YYYY-MM-DD)"),
-    limit: z
-        .number()
-        .min(1)
-        .max(100)
-        .optional()
-        .describe("Max results to return (default 25, max 100)"),
-    offset: z
-        .number()
-        .min(0)
-        .optional()
-        .describe("Pagination offset (default 0)"),
-}, async (params) => {
-    try {
-        const result = await searchInspections(params);
-        if (result.note) {
-            const xlsxUrls = get483XlsxUrls();
-            const summary = [
-                `## FDA Form 483 Inspections`,
-                ``,
-                `**Note:** ${result.note}`,
-                ``,
-                `### Alternative: Enriched Dataset`,
-                `Use the \`csa_risk_assessment\` or \`supplier_qualification_report\` tools to query 483 data from the enriched fda-csa-data dataset (179 individual observations + 6,714 aggregate citation rows).`,
-                ``,
-                `### FDA 483 XLSX Downloads (by fiscal year)`,
-            ];
-            for (const [fy, url] of Object.entries(xlsxUrls)) {
-                summary.push(`- **FY${fy}:** ${url}`);
-            }
-            return {
-                content: [{ type: "text", text: summary.join("\n") }],
-            };
-        }
-        if (result.inspections.length === 0) {
-            return {
-                content: [
-                    {
-                        type: "text",
-                        text: `No 483 inspection records found matching your criteria.`,
-                    },
-                ],
-            };
-        }
-        const summary = [
-            `## FDA Form 483 Inspections`,
-            `**Total results:** ${result.total}`,
-            `**Showing:** ${result.inspections.length} (offset ${params.offset ?? 0})`,
-            ``,
-        ];
-        for (const insp of result.inspections) {
-            summary.push(`### ${insp.firm_name}`);
-            summary.push(`- **FEI:** ${insp.fei_number}`);
-            summary.push(`- **Location:** ${[insp.city, insp.state, insp.country].filter(Boolean).join(", ")}`);
-            summary.push(`- **Inspection End:** ${insp.inspection_end_date}`);
-            summary.push(`- **Classification:** ${insp.classification}`);
-            summary.push(`- **Center:** ${insp.center}`);
-            summary.push(`- **Project Area:** ${insp.project_area}`);
-            if (insp.posted_citations)
-                summary.push(`- **Posted Citations:** ${insp.posted_citations}`);
-            if (insp.url)
-                summary.push(`- **URL:** ${insp.url}`);
-            summary.push(``);
-        }
-        return {
-            content: [{ type: "text", text: summary.join("\n") }],
-        };
+    const auth = validateApiKey();
+    if (!auth.valid) {
+        return { ok: false, content: [{ type: "text", text: auth.message }] };
     }
-    catch (error) {
+    return { ok: true };
+}
+async function enrichedConnectionGate() {
+    const gate = enrichedGate();
+    if (!gate.ok)
+        return gate;
+    const connected = await testConnection();
+    if (!connected) {
         return {
+            ok: false,
             content: [
                 {
                     type: "text",
-                    text: `Error searching 483 inspections: ${error instanceof Error ? error.message : String(error)}`,
+                    text: "Could not connect to the fda-csa-data database. Check your DATABASE_URL.",
                 },
             ],
-            isError: true,
         };
     }
-});
+    return { ok: true };
+}
 // ─── Tool: search_recalls ────────────────────────────────────────────────────
-server.tool("search_recalls", "Search FDA enforcement actions (recalls) via the openFDA API. Filter by product type, classification, firm, state, or date range.", {
-    search: z
-        .string()
-        .optional()
-        .describe("Free-text search across all recall fields"),
+server.tool("search_recalls", "Search FDA recalls and enforcement actions via the openFDA API. Covers drugs, devices, and food. Filter by severity, firm, state, or date range.", {
+    search: z.string().optional().describe("Free-text search across all recall fields"),
     product_type: z
         .enum(["drug", "device", "food"])
         .optional()
@@ -217,79 +66,98 @@ server.tool("search_recalls", "Search FDA enforcement actions (recalls) via the
         .enum(["Class I", "Class II", "Class III"])
         .optional()
         .describe("Recall classification (I = most serious)"),
-    recalling_firm: z
-        .string()
-        .optional()
-        .describe("Filter by recalling firm name"),
-    state: z
-        .string()
-        .optional()
-        .describe("Filter by US state (two-letter code)"),
-    date_from: z
-        .string()
-        .optional()
-        .describe("Start date for report date filter (YYYY-MM-DD)"),
-    date_to: z
-        .string()
-        .optional()
-        .describe("End date for report date filter (YYYY-MM-DD)"),
-    limit: z
-        .number()
-        .min(1)
-        .max(100)
-        .optional()
-        .describe("Max results to return (default 25, max 100)"),
-    skip: z
-        .number()
-        .min(0)
-        .optional()
-        .describe("Pagination skip (default 0)"),
+    recalling_firm: z.string().optional().describe("Filter by recalling firm name"),
+    state: z.string().optional().describe("Filter by US state (two-letter code)"),
+    date_from: z.string().optional().describe("Start date (YYYY-MM-DD)"),
+    date_to: z.string().optional().describe("End date (YYYY-MM-DD)"),
+    limit: z.number().min(1).max(100).optional().describe("Max results (default 25, max 100)"),
+    skip: z.number().min(0).optional().describe("Pagination offset (default 0)"),
 }, async (params) => {
     try {
         const result = await searchEnforcement(params);
         if (result.records.length === 0) {
-            return {
-                content: [
-                    {
-                        type: "text",
-                        text: `No recall/enforcement records found matching your criteria.`,
-                    },
-                ],
-            };
+            return { content: [{ type: "text", text: "No recalls found." }] };
         }
-        const summary = [
-            `## FDA Enforcement Actions (Recalls)`,
-            `**Total results:** ${result.total}`,
-            `**Showing:** ${result.records.length} (skip ${params.skip ?? 0})`,
+        const lines = [
+            `## FDA Recalls`,
+            `**${result.total} total** | Showing ${result.records.length}`,
             ``,
         ];
         for (const rec of result.records) {
-            summary.push(`### ${rec.recalling_firm} — ${rec.recall_number}`);
-            summary.push(`- **Classification:** ${rec.classification}`);
-            summary.push(`- **Status:** ${rec.status}`);
-            summary.push(`- **Product Type:** ${rec.product_type}`);
-            summary.push(`- **Location:** ${[rec.city, rec.state, rec.country].filter(Boolean).join(", ")}`);
-            summary.push(`- **Initiation Date:** ${rec.recall_initiation_date}`);
-            summary.push(`- **Reason:** ${rec.reason_for_recall}`);
+            lines.push(`### ${rec.recalling_firm} — ${rec.recall_number}`);
+            lines.push(`- **${rec.classification}** | ${rec.status} | ${rec.product_type} | ${rec.voluntary_mandated}`);
+            lines.push(`- **Location:** ${[rec.city, rec.state, rec.country].filter(Boolean).join(", ")}`);
+            lines.push(`- **Initiated:** ${rec.recall_initiation_date}`);
+            lines.push(`- **Reason:** ${rec.reason_for_recall}`);
             if (rec.product_description) {
                 const desc = rec.product_description.length > 200
                     ? rec.product_description.substring(0, 200) + "..."
                     : rec.product_description;
-                summary.push(`- **Product:** ${desc}`);
+                lines.push(`- **Product:** ${desc}`);
             }
-            summary.push(`- **Distribution:** ${rec.distribution_pattern}`);
-            summary.push(``);
+            lines.push(``);
         }
+        return { content: [{ type: "text", text: lines.join("\n") }] };
+    }
+    catch (error) {
         return {
-            content: [{ type: "text", text: summary.join("\n") }],
+            content: [
+                {
+                    type: "text",
+                    text: `Error: ${error instanceof Error ? error.message : String(error)}`,
+                },
+            ],
+            isError: true,
         };
     }
+});
+// ─── Tool: search_device_events ──────────────────────────────────────────────
+server.tool("search_device_events", "Search FDA device adverse events from the MAUDE database. Returns manufacturer, device, event type, patient outcomes, and narrative descriptions. Use this to assess post-market safety signals.", {
+    search: z.string().optional().describe("Free-text search across event fields"),
+    manufacturer: z.string().optional().describe("Filter by device manufacturer name"),
+    brand_name: z.string().optional().describe("Filter by device brand name"),
+    event_type: z
+        .enum(["Injury", "Malfunction", "Death", "Other"])
+        .optional()
+        .describe("Filter by event type"),
+    date_from: z.string().optional().describe("Start date (YYYY-MM-DD)"),
+    date_to: z.string().optional().describe("End date (YYYY-MM-DD)"),
+    limit: z.number().min(1).max(100).optional().describe("Max results (default 25, max 100)"),
+    skip: z.number().min(0).optional().describe("Pagination offset (default 0)"),
+}, async (params) => {
+    try {
+        const result = await searchDeviceEvents(params);
+        if (result.events.length === 0) {
+            return { content: [{ type: "text", text: "No device adverse events found." }] };
+        }
+        const lines = [
+            `## FDA Device Adverse Events (MAUDE)`,
+            `**${result.total} total** | Showing ${result.events.length}`,
+            ``,
+        ];
+        for (const evt of result.events) {
+            lines.push(`### ${evt.manufacturer || "Unknown"} — ${evt.report_number}`);
+            lines.push(`- **Event Type:** ${evt.event_type}`);
+            lines.push(`- **Device:** ${evt.brand_name || evt.device_name} (${evt.device_name})`);
+            lines.push(`- **Date Received:** ${evt.date_received}`);
+            if (evt.date_of_event)
+                lines.push(`- **Date of Event:** ${evt.date_of_event}`);
+            if (evt.event_description) {
+                const desc = evt.event_description.length > 300
+                    ? evt.event_description.substring(0, 300) + "..."
+                    : evt.event_description;
+                lines.push(`- **Description:** ${desc}`);
+            }
+            lines.push(``);
+        }
+        return { content: [{ type: "text", text: lines.join("\n") }] };
+    }
     catch (error) {
         return {
             content: [
                 {
                     type: "text",
-                    text: `Error searching recalls: ${error instanceof Error ? error.message : String(error)}`,
+                    text: `Error: ${error instanceof Error ? error.message : String(error)}`,
                 },
             ],
             isError: true,
@@ -297,65 +165,97 @@ server.tool("search_recalls", "Search FDA enforcement actions (recalls) via the
     }
 });
 // ─── Tool: company_enforcement_profile ───────────────────────────────────────
-server.tool("company_enforcement_profile", "Build a comprehensive enforcement profile for a company. Searches warning letters, 483 inspections, and recalls in parallel and returns a consolidated view. Use this to assess a company's FDA compliance posture.", {
-    company_name: z
-        .string()
-        .describe("Company or firm name to profile"),
+server.tool("company_enforcement_profile", "Build a comprehensive FDA enforcement profile for a company. Combines live openFDA recall and adverse event data with enriched warning letter and 483 inspection data (when available). Use this for a quick compliance posture check.", {
+    company_name: z.string().describe("Company or firm name to profile"),
     product_type: z
         .enum(["drug", "device", "food"])
         .optional()
-        .describe("Product type for recall search (default: drug)"),
+        .describe("Product type for recall search (default: device)"),
 }, async (params) => {
     try {
-        const [warnings, inspections, recalls] = await Promise.all([
-            searchWarningLetters({ search: params.company_name, limit: 10 }).catch(() => ({ total: 0, letters: [] })),
-            searchInspections({ firm_name: params.company_name, limit: 10 }).catch(() => ({ total: 0, inspections: [] })),
+        // Always fetch live openFDA data
+        const [recalls, events] = await Promise.all([
             searchEnforcement({
                 recalling_firm: params.company_name,
-                product_type: params.product_type,
-                limit: 10,
+                product_type: params.product_type ?? "device",
+                limit: 5,
             }).catch(() => ({ total: 0, records: [] })),
+            searchDeviceEvents({
+                manufacturer: params.company_name,
+                limit: 5,
+            }).catch(() => ({ total: 0, events: [] })),
         ]);
-        const summary = [
+        // Fetch enriched data if available
+        let enriched = null;
+        if (isEnrichedAvailable()) {
+            const connected = await testConnection().catch(() => false);
+            if (connected) {
+                enriched = await companyEnrichedProfile(params.company_name).catch(() => null);
+            }
+        }
+        const lines = [
             `## FDA Enforcement Profile: ${params.company_name}`,
             ``,
             `### Summary`,
-            `- **Warning Letters:** ${warnings.total} found`,
-            `- **483 Inspections:** ${inspections.total} found`,
-            `- **Recalls:** ${recalls.total} found`,
-            ``,
         ];
-        if (warnings.letters.length > 0) {
-            summary.push(`### Warning Letters (showing ${warnings.letters.length})`);
-            for (const l of warnings.letters) {
-                summary.push(`- **${l.issue_date}** | ${l.issuing_office} | ${l.subject}`);
+        if (enriched) {
+            lines.push(`- **Warning Letters:** ${enriched.total_warning_letters}`);
+            lines.push(`- **483 Inspections:** ${enriched.total_inspections}`);
+        }
+        lines.push(`- **Recalls:** ${recalls.total}`);
+        lines.push(`- **Adverse Events:** ${events.total}`);
+        lines.push(``);
+        // Warning letters (enriched)
+        if (enriched && enriched.warning_letters.length > 0) {
+            lines.push(`### Warning Letters (${enriched.total_warning_letters} total)`);
+            lines.push(`| Date | Center | Regime | CSA | Subject |`);
+            lines.push(`|------|--------|--------|-----|---------|`);
+            for (const wl of enriched.warning_letters) {
+                const subject = wl.subject.length > 40 ? wl.subject.substring(0, 40) + "..." : wl.subject;
+                lines.push(`| ${wl.issue_date} | ${wl.center} | ${wl.regime} | ${wl.csa_relevant ? "YES" : "no"} | ${subject} |`);
             }
-            summary.push(``);
+            lines.push(``);
         }
-        if (inspections.inspections.length > 0) {
-            summary.push(`### 483 Inspections (showing ${inspections.inspections.length})`);
-            for (const i of inspections.inspections) {
-                summary.push(`- **${i.inspection_end_date}** | ${i.center} | ${i.classification} | ${i.project_area}`);
+        // 483 inspections (enriched)
+        if (enriched && enriched.inspections.length > 0) {
+            lines.push(`### 483 Inspections (${enriched.total_inspections} total)`);
+            lines.push(`| Date | Center | Area | CSA |`);
+            lines.push(`|------|--------|------|-----|`);
+            for (const insp of enriched.inspections) {
+                lines.push(`| ${insp.inspection_date} | ${insp.center} | ${insp.product_area} | ${insp.csa_relevant ? "YES" : "no"} |`);
             }
-            summary.push(``);
+            lines.push(``);
         }
+        // Recalls (live)
         if (recalls.records.length > 0) {
-            summary.push(`### Recalls (showing ${recalls.records.length})`);
+            lines.push(`### Recalls (${recalls.total} total)`);
             for (const r of recalls.records) {
-                summary.push(`- **${r.recall_initiation_date}** | ${r.classification} | ${r.status} | ${r.reason_for_recall.substring(0, 120)}...`);
+                lines.push(`- **${r.recall_initiation_date}** | ${r.classification} | ${r.status} | ${r.reason_for_recall.substring(0, 100)}...`);
             }
-            summary.push(``);
+            lines.push(``);
         }
-        return {
-            content: [{ type: "text", text: summary.join("\n") }],
-        };
+        // Adverse events (live)
+        if (events.events.length > 0) {
+            lines.push(`### Recent Adverse Events (${events.total} total)`);
+            for (const e of events.events) {
+                lines.push(`- **${e.date_received}** | ${e.event_type} | ${e.brand_name || e.device_name} | ${e.manufacturer}`);
+            }
+            lines.push(``);
+        }
+        if (!enriched && isEnrichedAvailable()) {
+            lines.push(`*Note: Enriched data unavailable. Set DATABASE_URL to include warning letters and 483 inspection data.*`);
+        }
+        else if (!enriched) {
+            lines.push(`*Tip: Enable enriched tools (DATABASE_URL) to include warning letters, 483 inspections, and CSA analysis.*`);
+        }
+        return { content: [{ type: "text", text: lines.join("\n") }] };
     }
     catch (error) {
         return {
             content: [
                 {
                     type: "text",
-                    text: `Error building enforcement profile: ${error instanceof Error ? error.message : String(error)}`,
+                    text: `Error: ${error instanceof Error ? error.message : String(error)}`,
                 },
             ],
             isError: true,
@@ -363,53 +263,22 @@ server.tool("company_enforcement_profile", "Build a comprehensive enforcement pr
     }
 });
 // ─── Enriched Tools (require DATABASE_URL → fda-csa-data PostgreSQL) ─────────
-// Tool: csa_risk_assessment
-server.tool("csa_risk_assessment", "Assess a company's Computer Software Assurance (CSA) enforcement risk using enriched FDA dataset. Returns risk score, CSA-specific citation counts, failure modes, and escalation analysis. Requires DATABASE_URL environment variable pointing to the fda-csa-data PostgreSQL database.", {
-    company_name: z
-        .string()
-        .describe("Company or firm name to assess"),
+server.tool("csa_risk_assessment", "Assess a company's Computer Software Assurance (CSA) enforcement risk. Returns risk score, CSA-specific citation counts, failure modes, and escalation analysis from the enriched fda-csa-data dataset.", {
+    company_name: z.string().describe("Company or firm name to assess"),
 }, async (params) => {
-    if (!isEnrichedAvailable()) {
-        return {
-            content: [
-                {
-                    type: "text",
-                    text: `CSA risk assessment requires the enriched dataset. Set DATABASE_URL to your fda-csa-data PostgreSQL instance.\n\nSee: https://github.com/jasencarroll/fda-csa-data for setup instructions.\n\nFalling back: use the \`company_enforcement_profile\` tool for live FDA data without CSA analysis.`,
-                },
-            ],
-        };
-    }
-    const auth = validateApiKey();
-    if (!auth.valid) {
-        return {
-            content: [{ type: "text", text: auth.message }],
-        };
-    }
+    const gate = await enrichedConnectionGate();
+    if (!gate.ok)
+        return { content: gate.content };
     try {
-        const connected = await testConnection();
-        if (!connected) {
-            return {
-                content: [
-                    {
-                        type: "text",
-                        text: `Could not connect to the fda-csa-data database. Check your DATABASE_URL.`,
-                    },
-                ],
-                isError: true,
-            };
-        }
         const result = await csaRiskAssessment(params.company_name);
         if (!result) {
             return {
                 content: [
-                    {
-                        type: "text",
-                        text: `No data found for "${params.company_name}" in the enriched dataset.`,
-                    },
+                    { type: "text", text: `No data found for "${params.company_name}".` },
                 ],
             };
         }
-        const summary = [
+        const lines = [
             `## CSA Risk Assessment: ${result.company_name}`,
             ``,
             `### Risk Score: ${result.risk_score} — ${result.risk_level}`,
@@ -420,97 +289,53 @@ server.tool("csa_risk_assessment", "Assess a company's Computer Software Assuran
             `| Citations | ${result.total_citations} | ${result.csa_citations} |`,
             `| 483 Inspections | ${result.inspection_count} | ${result.csa_inspection_count} |`,
             ``,
-            `**Escalation Multiplier:** ${result.escalation_multiplier}x (CSA findings on 483s are ${result.escalation_multiplier}x more likely to become warning letters)`,
+            `**Escalation Multiplier:** ${result.escalation_multiplier}x`,
             ``,
         ];
         if (result.top_cfr_citations.length > 0) {
-            summary.push(`### Top CFR Citations`);
+            lines.push(`### Top CFR Citations`);
             for (const c of result.top_cfr_citations) {
-                summary.push(`- **${c.cfr_full}** (${c.category}) — ${c.count} citations`);
+                lines.push(`- **${c.cfr_full}** (${c.category}) — ${c.count}`);
             }
-            summary.push(``);
+            lines.push(``);
         }
         if (result.failure_modes.length > 0) {
-            summary.push(`### Identified Failure Modes`);
+            lines.push(`### Failure Modes`);
             for (const fm of result.failure_modes) {
-                summary.push(`- ${fm}`);
+                lines.push(`- ${fm}`);
             }
-            summary.push(``);
+            lines.push(``);
         }
-        return {
-            content: [{ type: "text", text: summary.join("\n") }],
-        };
+        return { content: [{ type: "text", text: lines.join("\n") }] };
     }
     catch (error) {
         return {
             content: [
                 {
                     type: "text",
-                    text: `Error running CSA risk assessment: ${error instanceof Error ? error.message : String(error)}`,
+                    text: `Error: ${error instanceof Error ? error.message : String(error)}`,
                 },
             ],
             isError: true,
         };
     }
 });
-// Tool: citation_analysis
-server.tool("citation_analysis", "Analyze FDA citation patterns across warning letters. Break down by CFR part, section, category, and type. Identify CSA-relevant citation percentages. Requires DATABASE_URL environment variable.", {
-    cfr_part: z
-        .string()
-        .optional()
-        .describe("Filter by CFR part (e.g., '820', '211', '11')"),
+server.tool("citation_analysis", "Analyze FDA citation patterns across warning letters. Break down by CFR part, section, category, and type. Identify CSA-relevant percentages. Powered by the enriched fda-csa-data dataset.", {
+    cfr_part: z.string().optional().describe("Filter by CFR part (e.g., '820', '211', '11')"),
     category: z
         .string()
         .optional()
-        .describe("Filter by normalized category (e.g., 'software_validation', 'data_integrity', 'design_controls')"),
-    center: z
-        .string()
-        .optional()
-        .describe("Filter by FDA center (e.g., 'CDRH', 'CDER')"),
-    fiscal_year: z
-        .number()
-        .optional()
-        .describe("Filter by fiscal year (e.g., 2024, 2025)"),
+        .describe("Filter by category (e.g., 'software_validation', 'design_controls', 'capa')"),
+    center: z.string().optional().describe("Filter by FDA center (e.g., 'CDRH', 'CDER')"),
+    fiscal_year: z.number().optional().describe("Filter by fiscal year (e.g., 2024, 2025)"),
 }, async (params) => {
-    if (!isEnrichedAvailable()) {
-        return {
-            content: [
-                {
-                    type: "text",
-                    text: `Citation analysis requires the enriched dataset. Set DATABASE_URL to your fda-csa-data PostgreSQL instance.\n\nSee: https://github.com/jasencarroll/fda-csa-data`,
-                },
-            ],
-        };
-    }
-    const auth = validateApiKey();
-    if (!auth.valid) {
-        return {
-            content: [{ type: "text", text: auth.message }],
-        };
-    }
+    const gate = await enrichedConnectionGate();
+    if (!gate.ok)
+        return { content: gate.content };
     try {
-        const connected = await testConnection();
-        if (!connected) {
-            return {
-                content: [
-                    {
-                        type: "text",
-                        text: `Could not connect to the fda-csa-data database. Check your DATABASE_URL.`,
-                    },
-                ],
-                isError: true,
-            };
-        }
         const result = await citationAnalysis(params);
         if (!result) {
-            return {
-                content: [
-                    {
-                        type: "text",
-                        text: `No citation data found for the given filters.`,
-                    },
-                ],
-            };
+            return { content: [{ type: "text", text: "No citation data found." }] };
         }
         const filters = [
             params.cfr_part && `CFR Part ${params.cfr_part}`,
@@ -520,191 +345,134 @@ server.tool("citation_analysis", "Analyze FDA citation patterns across warning l
         ]
             .filter(Boolean)
             .join(" | ");
-        const summary = [
+        const lines = [
             `## FDA Citation Analysis`,
             filters ? `**Filters:** ${filters}` : `**Scope:** All citations`,
-            `**Total Citations:** ${result.total_citations}`,
-            `**CSA-Relevant:** ${result.csa_percentage}%`,
+            `**Total:** ${result.total_citations} | **CSA-Relevant:** ${result.csa_percentage}%`,
             ``,
         ];
         if (result.by_cfr_part.length > 0) {
-            summary.push(`### By CFR Part`);
+            lines.push(`### By CFR Part`);
             for (const p of result.by_cfr_part) {
-                summary.push(`- **Part ${p.part}** — ${p.count} citations`);
+                lines.push(`- **Part ${p.part}** — ${p.count}`);
             }
-            summary.push(``);
+            lines.push(``);
         }
         if (result.by_category.length > 0) {
-            summary.push(`### By Category`);
+            lines.push(`### By Category`);
             for (const c of result.by_category) {
-                const csa = c.csa_relevant ? " ⚠ CSA" : "";
-                summary.push(`- **${c.category}** — ${c.count}${csa}`);
+                const csa = c.csa_relevant ? " (CSA)" : "";
+                lines.push(`- **${c.category}** — ${c.count}${csa}`);
             }
-            summary.push(``);
+            lines.push(``);
         }
         if (result.top_sections.length > 0) {
-            summary.push(`### Top CFR Sections`);
+            lines.push(`### Top Sections`);
             for (const s of result.top_sections) {
-                summary.push(`- **${s.cfr_full}** (${s.description}) — ${s.count}`);
+                lines.push(`- **${s.cfr_full}** (${s.description}) — ${s.count}`);
             }
-            summary.push(``);
+            lines.push(``);
         }
-        if (result.by_type.length > 0) {
-            summary.push(`### By Citation Type`);
-            for (const t of result.by_type) {
-                summary.push(`- **${t.type}** — ${t.count}`);
-            }
-            summary.push(``);
-        }
-        return {
-            content: [{ type: "text", text: summary.join("\n") }],
-        };
+        return { content: [{ type: "text", text: lines.join("\n") }] };
     }
     catch (error) {
         return {
             content: [
                 {
                     type: "text",
-                    text: `Error running citation analysis: ${error instanceof Error ? error.message : String(error)}`,
+                    text: `Error: ${error instanceof Error ? error.message : String(error)}`,
                 },
             ],
             isError: true,
         };
     }
 });
-// Tool: supplier_qualification_report
-server.tool("supplier_qualification_report", "Generate a comprehensive supplier qualification report for FDA-regulated supplier assessments. Consolidates warning letters, 483 inspections, citations, failure modes, and CSA risk into a single audit-ready brief. Requires DATABASE_URL environment variable.", {
-    company_name: z
-        .string()
-        .describe("Supplier/company name to qualify"),
+server.tool("supplier_qualification_report", "Generate an audit-ready supplier qualification report. Consolidates warning letters, 483 inspections, citations, failure modes, and CSA risk into a single brief with a qualification recommendation. Powered by the enriched fda-csa-data dataset.", {
+    company_name: z.string().describe("Supplier/company name to qualify"),
 }, async (params) => {
-    if (!isEnrichedAvailable()) {
-        return {
-            content: [
-                {
-                    type: "text",
-                    text: `Supplier qualification report requires the enriched dataset. Set DATABASE_URL to your fda-csa-data PostgreSQL instance.\n\nSee: https://github.com/jasencarroll/fda-csa-data\n\nFor a lighter-weight alternative, use the \`company_enforcement_profile\` tool.`,
-                },
-            ],
-        };
-    }
-    const auth = validateApiKey();
-    if (!auth.valid) {
-        return {
-            content: [{ type: "text", text: auth.message }],
-        };
-    }
+    const gate = await enrichedConnectionGate();
+    if (!gate.ok)
+        return { content: gate.content };
     try {
-        const connected = await testConnection();
-        if (!connected) {
-            return {
-                content: [
-                    {
-                        type: "text",
-                        text: `Could not connect to the fda-csa-data database. Check your DATABASE_URL.`,
-                    },
-                ],
-                isError: true,
-            };
-        }
         const result = await supplierQualification(params.company_name);
         if (!result) {
             return {
                 content: [
-                    {
-                        type: "text",
-                        text: `No data found for "${params.company_name}" in the enriched dataset.`,
-                    },
+                    { type: "text", text: `No data found for "${params.company_name}".` },
                 ],
             };
         }
-        const summary = [
+        const lines = [
             `## Supplier Qualification Report: ${result.company_name}`,
             `*Generated ${new Date().toISOString().split("T")[0]}*`,
             ``,
         ];
-        // Risk summary
         if (result.csa_risk) {
-            summary.push(`### CSA Risk Assessment`);
-            summary.push(`- **Risk Score:** ${result.csa_risk.risk_score} — **${result.csa_risk.risk_level}**`);
-            summary.push(`- **CSA Warning Letters:** ${result.csa_risk.csa_warning_letter_count} of ${result.csa_risk.warning_letter_count}`);
-            summary.push(`- **CSA Inspections:** ${result.csa_risk.csa_inspection_count} of ${result.csa_risk.inspection_count}`);
-            summary.push(`- **CSA Citations:** ${result.csa_risk.csa_citations} of ${result.csa_risk.total_citations}`);
-            summary.push(``);
+            lines.push(`### CSA Risk Assessment`);
+            lines.push(`- **Risk Score:** ${result.csa_risk.risk_score} — **${result.csa_risk.risk_level}**`);
+            lines.push(`- **CSA Warning Letters:** ${result.csa_risk.csa_warning_letter_count} of ${result.csa_risk.warning_letter_count}`);
+            lines.push(`- **CSA Inspections:** ${result.csa_risk.csa_inspection_count} of ${result.csa_risk.inspection_count}`);
+            lines.push(`- **CSA Citations:** ${result.csa_risk.csa_citations} of ${result.csa_risk.total_citations}`);
+            lines.push(``);
         }
-        // FEI numbers
         if (result.fei_numbers.length > 0) {
-            summary.push(`### Facility Establishment Identifiers (FEI)`);
+            lines.push(`### Facility Establishment Identifiers (FEI)`);
             for (const fei of result.fei_numbers) {
-                summary.push(`- ${fei}`);
+                lines.push(`- ${fei}`);
             }
-            summary.push(``);
+            lines.push(``);
         }
-        // Warning letters
         if (result.warning_letters.length > 0) {
-            summary.push(`### Warning Letters (${result.warning_letters.length})`);
-            summary.push(`| Date | Center | Regime | CSA |`);
-            summary.push(`|------|--------|--------|-----|`);
+            lines.push(`### Warning Letters (${result.warning_letters.length})`);
+            lines.push(`| Date | Center | Regime | CSA |`);
+            lines.push(`|------|--------|--------|-----|`);
             for (const wl of result.warning_letters) {
-                summary.push(`| ${wl.issue_date} | ${wl.center} | ${wl.regime} | ${wl.csa_relevant ? "YES" : "no"} |`);
+                lines.push(`| ${wl.issue_date} | ${wl.center} | ${wl.regime} | ${wl.csa_relevant ? "YES" : "no"} |`);
             }
-            summary.push(``);
+            lines.push(``);
         }
-        // Inspections
         if (result.inspections.length > 0) {
-            summary.push(`### Form 483 Inspections (${result.inspections.length})`);
-            summary.push(`| Date | Center | Area | CSA |`);
-            summary.push(`|------|--------|------|-----|`);
+            lines.push(`### Form 483 Inspections (${result.inspections.length})`);
+            lines.push(`| Date | Center | Area | CSA |`);
+            lines.push(`|------|--------|------|-----|`);
             for (const insp of result.inspections) {
-                summary.push(`| ${insp.inspection_end_date} | ${insp.center} | ${insp.product_area} | ${insp.csa_relevant ? "YES" : "no"} |`);
+                lines.push(`| ${insp.inspection_end_date} | ${insp.center} | ${insp.product_area} | ${insp.csa_relevant ? "YES" : "no"} |`);
             }
-            summary.push(``);
+            lines.push(``);
         }
-        // Citations
         if (result.citation_summary.length > 0) {
-            summary.push(`### Citation Summary`);
+            lines.push(`### Citation Summary`);
             for (const c of result.citation_summary) {
-                summary.push(`- **${c.cfr_full}** (${c.category}) — ${c.count}x`);
+                lines.push(`- **${c.cfr_full}** (${c.category}) — ${c.count}x`);
             }
-            summary.push(``);
+            lines.push(``);
         }
-        // Failure modes
         if (result.failure_modes.length > 0) {
-            summary.push(`### Identified Failure Modes`);
+            lines.push(`### Failure Modes`);
             for (const fm of result.failure_modes) {
-                summary.push(`- **${fm.mode}** (${fm.confidence} confidence) — ${fm.count}x`);
+                lines.push(`- **${fm.mode}** (confidence: ${fm.confidence}) — ${fm.count}x`);
             }
-            summary.push(``);
+            lines.push(``);
         }
-        // Recommendation
         if (result.csa_risk) {
-            summary.push(`### Qualification Recommendation`);
-            switch (result.csa_risk.risk_level) {
-                case "CRITICAL":
-                    summary.push(`**DO NOT QUALIFY without on-site audit.** Critical CSA enforcement history. Requires detailed remediation evidence review, CAPA verification, and management commitment assessment before supplier approval.`);
-                    break;
-                case "HIGH":
-                    summary.push(`**Conditional qualification.** Significant CSA enforcement history warrants enhanced supplier monitoring. Require CAPA documentation for all cited findings. Schedule qualification audit within 90 days.`);
-                    break;
-                case "MODERATE":
-                    summary.push(`**Qualify with enhanced monitoring.** Enforcement history present but manageable. Include CSA-specific questions in supplier questionnaire. Annual re-evaluation recommended.`);
-                    break;
-                case "LOW":
-                    summary.push(`**Standard qualification pathway.** No significant CSA enforcement concerns. Proceed with standard supplier qualification process.`);
-                    break;
-            }
-            summary.push(``);
+            lines.push(`### Qualification Recommendation`);
+            const rec = {
+                CRITICAL: "**DO NOT QUALIFY without on-site audit.** Critical CSA enforcement history requires remediation evidence, CAPA verification, and management commitment assessment.",
+                HIGH: "**Conditional qualification.** Significant CSA enforcement history. Require CAPA documentation for all cited findings. Schedule audit within 90 days.",
+                MODERATE: "**Qualify with enhanced monitoring.** Enforcement history present but manageable. Include CSA-specific questions in supplier questionnaire. Annual re-evaluation.",
+                LOW: "**Standard qualification pathway.** No significant CSA enforcement concerns.",
+            };
+            lines.push(rec[result.csa_risk.risk_level] ?? "Insufficient data for recommendation.");
+            lines.push(``);
         }
-        return {
-            content: [{ type: "text", text: summary.join("\n") }],
-        };
+        return { content: [{ type: "text", text: lines.join("\n") }] };
     }
     catch (error) {
         return {
             content: [
                 {
                     type: "text",
-                    text: `Error generating supplier qualification report: ${error instanceof Error ? error.message : String(error)}`,
+                    text: `Error: ${error instanceof Error ? error.message : String(error)}`,
                 },
             ],
             isError: true,
@@ -716,17 +484,17 @@ async function main() {
     const transport = new StdioServerTransport();
     await server.connect(transport);
     const enriched = isEnrichedAvailable();
-    console.error(`FDA MCP Server running on stdio`);
-    console.error(`  Tools: search_warning_letters, search_483_inspections, search_recalls, company_enforcement_profile`);
+    console.error("FDA MCP Server running on stdio");
+    console.error("  Tools: search_recalls, search_device_events, company_enforcement_profile");
     if (enriched) {
         const connected = await testConnection();
         console.error(`  Enriched tools: ${connected ? "ACTIVE" : "DATABASE_URL set but connection failed"}`);
         if (connected) {
-            console.error(`  + csa_risk_assessment, citation_analysis, supplier_qualification_report`);
+            console.error("  + csa_risk_assessment, citation_analysis, supplier_qualification_report");
         }
     }
     else {
-        console.error(`  Enriched tools: INACTIVE (set DATABASE_URL to enable)`);
+        console.error("  Enriched tools: INACTIVE (set DATABASE_URL to enable)");
     }
 }
 main().catch((error) => {