fda-mcp-server 0.0.13 → 0.0.14

package/dist/index.js

@@ -15,10 +15,16 @@ import { WebStandardStreamableHTTPServerTransport } from "@modelcontextprotocol/
 import { z } from "zod";
 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",
-});
+function createServer() {
+    const server = new McpServer({
+        name: "fda-mcp-server",
+        version: "1.0.0",
+    });
+    registerTools(server);
+    return server;
+}
+// Single server instance for stdio mode
+let stdioServer = null;
 // ─── Helper: gate enriched tools ─────────────────────────────────────────────
 function enrichedGate(apiKey) {
     if (!isEnrichedAvailable()) {
@@ -56,431 +62,433 @@ async function enrichedConnectionGate(apiKey) {
     }
     return { ok: true };
 }
-// ─── Tool: search_recalls ────────────────────────────────────────────────────
-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()
-        .describe("Product type (default: drug)"),
-    classification: z
-        .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 (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 recalls found." }] };
-        }
-        const lines = [
-            `## FDA Recalls`,
-            `**${result.total} total** | Showing ${result.records.length}`,
-            ``,
-        ];
-        for (const rec of result.records) {
-            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;
-                lines.push(`- **Product:** ${desc}`);
+function registerTools(server) {
+    // ─── Tool: search_recalls ────────────────────────────────────────────────────
+    server.tool("search_recalls", "Search FDA recalls and enforcement actions via the openFDA API. Covers drugs, devices, and food. Filter by severity, firm, state, or date range.", {
+        search: z.string().optional().describe("Free-text search across all recall fields"),
+        product_type: z
+            .enum(["drug", "device", "food"])
+            .optional()
+            .describe("Product type (default: drug)"),
+        classification: z
+            .enum(["Class I", "Class II", "Class III"])
+            .optional()
+            .describe("Recall classification (I = most serious)"),
+        recalling_firm: z.string().optional().describe("Filter by recalling firm name"),
+        state: z.string().optional().describe("Filter by US state (two-letter code)"),
+        date_from: z.string().optional().describe("Start date (YYYY-MM-DD)"),
+        date_to: z.string().optional().describe("End date (YYYY-MM-DD)"),
+        limit: z.number().min(1).max(100).optional().describe("Max results (default 25, max 100)"),
+        skip: z.number().min(0).optional().describe("Pagination offset (default 0)"),
+    }, async (params) => {
+        try {
+            const result = await searchEnforcement(params);
+            if (result.records.length === 0) {
+                return { content: [{ type: "text", text: "No recalls found." }] };
             }
-            lines.push(``);
+            const lines = [
+                `## FDA Recalls`,
+                `**${result.total} total** | Showing ${result.records.length}`,
+                ``,
+            ];
+            for (const rec of result.records) {
+                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;
+                    lines.push(`- **Product:** ${desc}`);
+                }
+                lines.push(``);
+            }
+            return { content: [{ type: "text", text: lines.join("\n") }] };
         }
-        return { content: [{ type: "text", text: lines.join("\n") }] };
-    }
-    catch (error) {
-        return {
-            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." }] };
+        catch (error) {
+            return {
+                content: [
+                    {
+                        type: "text",
+                        text: `Error: ${error instanceof Error ? error.message : String(error)}`,
+                    },
+                ],
+                isError: true,
+            };
         }
-        const lines = [
-            `## FDA Device Adverse Events (MAUDE)`,
-            `**${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}`);
+    });
+    // ─── 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." }] };
             }
-            lines.push(``);
-        }
-        return { content: [{ type: "text", text: lines.join("\n") }] };
-    }
-    catch (error) {
-        return {
-            content: [
-                {
-                    type: "text",
-                    text: `Error: ${error instanceof Error ? error.message : String(error)}`,
-                },
-            ],
-            isError: true,
-        };
-    }
-});
-// ─── Tool: company_enforcement_profile ───────────────────────────────────────
-server.tool("company_enforcement_profile", "Build a comprehensive FDA enforcement profile for a company. Combines live openFDA recall and adverse event data with enriched warning letter and 483 inspection data (when available). Use this for a quick compliance posture check.", {
-    company_name: z.string().describe("Company or firm name to profile"),
-    product_type: z
-        .enum(["drug", "device", "food"])
-        .optional()
-        .describe("Product type for recall search (default: device)"),
-}, async (params, extra) => {
-    try {
-        // Always fetch live openFDA data
-        const [recalls, events] = await Promise.all([
-            searchEnforcement({
-                recalling_firm: params.company_name,
-                product_type: params.product_type ?? "device",
-                limit: 5,
-            }).catch(() => ({ total: 0, records: [] })),
-            searchDeviceEvents({
-                manufacturer: params.company_name,
-                limit: 5,
-            }).catch(() => ({ total: 0, events: [] })),
-        ]);
-        // Fetch enriched data if available and authorized
-        let enriched = null;
-        const authCheck = enrichedGate(extra.authInfo?.token);
-        if (authCheck.ok) {
-            const connected = await testConnection().catch(() => false);
-            if (connected) {
-                enriched = await companyEnrichedProfile(params.company_name).catch(() => null);
+            const lines = [
+                `## FDA Device Adverse Events (MAUDE)`,
+                `**${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") }] };
         }
-        const lines = [
-            `## FDA Enforcement Profile: ${params.company_name}`,
-            ``,
-            `### Summary`,
-        ];
-        if (enriched) {
-            lines.push(`- **Warning Letters:** ${enriched.total_warning_letters}`);
-            lines.push(`- **483 Inspections:** ${enriched.total_inspections}`);
+        catch (error) {
+            return {
+                content: [
+                    {
+                        type: "text",
+                        text: `Error: ${error instanceof Error ? error.message : String(error)}`,
+                    },
+                ],
+                isError: true,
+            };
         }
-        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"} | ${subject} |`);
+    });
+    // ─── Tool: company_enforcement_profile ───────────────────────────────────────
+    server.tool("company_enforcement_profile", "Build a comprehensive FDA enforcement profile for a company. Combines live openFDA recall and adverse event data with enriched warning letter and 483 inspection data (when available). Use this for a quick compliance posture check.", {
+        company_name: z.string().describe("Company or firm name to profile"),
+        product_type: z
+            .enum(["drug", "device", "food"])
+            .optional()
+            .describe("Product type for recall search (default: device)"),
+    }, async (params, extra) => {
+        try {
+            // Always fetch live openFDA data
+            const [recalls, events] = await Promise.all([
+                searchEnforcement({
+                    recalling_firm: params.company_name,
+                    product_type: params.product_type ?? "device",
+                    limit: 5,
+                }).catch(() => ({ total: 0, records: [] })),
+                searchDeviceEvents({
+                    manufacturer: params.company_name,
+                    limit: 5,
+                }).catch(() => ({ total: 0, events: [] })),
+            ]);
+            // Fetch enriched data if available and authorized
+            let enriched = null;
+            const authCheck = enrichedGate(extra.authInfo?.token);
+            if (authCheck.ok) {
+                const connected = await testConnection().catch(() => false);
+                if (connected) {
+                    enriched = await companyEnrichedProfile(params.company_name).catch(() => null);
+                }
             }
-            lines.push(``);
-        }
-        // 483 inspections (enriched)
-        if (enriched && enriched.inspections.length > 0) {
-            lines.push(`### 483 Inspections (${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"} |`);
+            const lines = [
+                `## FDA Enforcement Profile: ${params.company_name}`,
+                ``,
+                `### Summary`,
+            ];
+            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:** ${events.total}`);
             lines.push(``);
-        }
-        // Recalls (live)
-        if (recalls.records.length > 0) {
-            lines.push(`### Recalls (${recalls.total} total)`);
-            for (const r of recalls.records) {
-                lines.push(`- **${r.recall_initiation_date}** | ${r.classification} | ${r.status} | ${r.reason_for_recall.substring(0, 100)}...`);
+            // Warning letters (enriched)
+            if (enriched && enriched.warning_letters.length > 0) {
+                lines.push(`### Warning Letters (${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"} | ${subject} |`);
+                }
+                lines.push(``);
             }
-            lines.push(``);
-        }
-        // Adverse events (live)
-        if (events.events.length > 0) {
-            lines.push(`### Recent Adverse Events (${events.total} total)`);
-            for (const e of events.events) {
-                lines.push(`- **${e.date_received}** | ${e.event_type} | ${e.brand_name || e.device_name} | ${e.manufacturer}`);
+            // 483 inspections (enriched)
+            if (enriched && enriched.inspections.length > 0) {
+                lines.push(`### 483 Inspections (${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} | ${insp.csa_relevant ? "YES" : "no"} |`);
+                }
+                lines.push(``);
             }
-            lines.push(``);
-        }
-        if (!enriched && isEnrichedAvailable()) {
-            lines.push(`*Note: Enriched data unavailable. Set DATABASE_URL to include warning letters and 483 inspection data.*`);
-        }
-        else if (!enriched) {
-            lines.push(`*Tip: Enable enriched tools (DATABASE_URL) to include warning letters, 483 inspections, and CSA analysis.*`);
+            // Recalls (live)
+            if (recalls.records.length > 0) {
+                lines.push(`### Recalls (${recalls.total} total)`);
+                for (const r of recalls.records) {
+                    lines.push(`- **${r.recall_initiation_date}** | ${r.classification} | ${r.status} | ${r.reason_for_recall.substring(0, 100)}...`);
+                }
+                lines.push(``);
+            }
+            // Adverse events (live)
+            if (events.events.length > 0) {
+                lines.push(`### Recent Adverse Events (${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") }] };
         }
-        return { content: [{ type: "text", text: lines.join("\n") }] };
-    }
-    catch (error) {
-        return {
-            content: [
-                {
-                    type: "text",
-                    text: `Error: ${error instanceof Error ? error.message : String(error)}`,
-                },
-            ],
-            isError: true,
-        };
-    }
-});
-// ─── Enriched Tools (require DATABASE_URL → fda-csa-data PostgreSQL) ─────────
-server.tool("csa_risk_assessment", "Assess a company's Computer Software Assurance (CSA) enforcement risk. Returns risk score, CSA-specific citation counts, failure modes, and escalation analysis from the enriched fda-csa-data dataset.", {
-    company_name: z.string().describe("Company or firm name to assess"),
-}, async (params, extra) => {
-    const gate = await enrichedConnectionGate(extra.authInfo?.token);
-    if (!gate.ok)
-        return { content: gate.content };
-    try {
-        const result = await csaRiskAssessment(params.company_name);
-        if (!result) {
+        catch (error) {
             return {
                 content: [
-                    { type: "text", text: `No data found for "${params.company_name}".` },
+                    {
+                        type: "text",
+                        text: `Error: ${error instanceof Error ? error.message : String(error)}`,
+                    },
                 ],
+                isError: true,
             };
         }
-        const lines = [
-            `## CSA Risk Assessment: ${result.company_name}`,
-            ``,
-            `### Risk Score: ${result.risk_score} — ${result.risk_level}`,
-            ``,
-            `| Metric | Total | CSA-Specific |`,
-            `|--------|------:|-------------:|`,
-            `| Warning Letters | ${result.warning_letter_count} | ${result.csa_warning_letter_count} |`,
-            `| Citations | ${result.total_citations} | ${result.csa_citations} |`,
-            `| 483 Inspections | ${result.inspection_count} | ${result.csa_inspection_count} |`,
-            ``,
-            `**Escalation Multiplier:** ${result.escalation_multiplier}x`,
-            ``,
-        ];
-        if (result.top_cfr_citations.length > 0) {
-            lines.push(`### Top CFR Citations`);
-            for (const c of result.top_cfr_citations) {
-                lines.push(`- **${c.cfr_full}** (${c.category}) — ${c.count}`);
+    });
+    // ─── Enriched Tools (require DATABASE_URL → fda-csa-data PostgreSQL) ─────────
+    server.tool("csa_risk_assessment", "Assess a company's Computer Software Assurance (CSA) enforcement risk. Returns risk score, CSA-specific citation counts, failure modes, and escalation analysis from the enriched fda-csa-data dataset.", {
+        company_name: z.string().describe("Company or firm name to assess"),
+    }, async (params, extra) => {
+        const gate = await enrichedConnectionGate(extra.authInfo?.token);
+        if (!gate.ok)
+            return { content: gate.content };
+        try {
+            const result = await csaRiskAssessment(params.company_name);
+            if (!result) {
+                return {
+                    content: [
+                        { type: "text", text: `No data found for "${params.company_name}".` },
+                    ],
+                };
             }
-            lines.push(``);
-        }
-        if (result.failure_modes.length > 0) {
-            lines.push(`### Failure Modes`);
-            for (const fm of result.failure_modes) {
-                lines.push(`- ${fm}`);
+            const lines = [
+                `## CSA Risk Assessment: ${result.company_name}`,
+                ``,
+                `### Risk Score: ${result.risk_score} — ${result.risk_level}`,
+                ``,
+                `| Metric | Total | CSA-Specific |`,
+                `|--------|------:|-------------:|`,
+                `| Warning Letters | ${result.warning_letter_count} | ${result.csa_warning_letter_count} |`,
+                `| Citations | ${result.total_citations} | ${result.csa_citations} |`,
+                `| 483 Inspections | ${result.inspection_count} | ${result.csa_inspection_count} |`,
+                ``,
+                `**Escalation Multiplier:** ${result.escalation_multiplier}x`,
+                ``,
+            ];
+            if (result.top_cfr_citations.length > 0) {
+                lines.push(`### Top CFR Citations`);
+                for (const c of result.top_cfr_citations) {
+                    lines.push(`- **${c.cfr_full}** (${c.category}) — ${c.count}`);
+                }
+                lines.push(``);
             }
-            lines.push(``);
+            if (result.failure_modes.length > 0) {
+                lines.push(`### Failure Modes`);
+                for (const fm of result.failure_modes) {
+                    lines.push(`- ${fm}`);
+                }
+                lines.push(``);
+            }
+            return { content: [{ type: "text", text: lines.join("\n") }] };
         }
-        return { content: [{ type: "text", text: lines.join("\n") }] };
-    }
-    catch (error) {
-        return {
-            content: [
-                {
-                    type: "text",
-                    text: `Error: ${error instanceof Error ? error.message : String(error)}`,
-                },
-            ],
-            isError: true,
-        };
-    }
-});
-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 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, extra) => {
-    const gate = await enrichedConnectionGate(extra.authInfo?.token);
-    if (!gate.ok)
-        return { content: gate.content };
-    try {
-        const result = await citationAnalysis(params);
-        if (!result) {
-            return { content: [{ type: "text", text: "No citation data found." }] };
+        catch (error) {
+            return {
+                content: [
+                    {
+                        type: "text",
+                        text: `Error: ${error instanceof Error ? error.message : String(error)}`,
+                    },
+                ],
+                isError: true,
+            };
         }
-        const filters = [
-            params.cfr_part && `CFR Part ${params.cfr_part}`,
-            params.category && `Category: ${params.category}`,
-            params.center && `Center: ${params.center}`,
-            params.fiscal_year && `FY${params.fiscal_year}`,
-        ]
-            .filter(Boolean)
-            .join(" | ");
-        const lines = [
-            `## FDA Citation Analysis`,
-            filters ? `**Filters:** ${filters}` : `**Scope:** All citations`,
-            `**Total:** ${result.total_citations} | **CSA-Relevant:** ${result.csa_percentage}%`,
-            ``,
-        ];
-        if (result.by_cfr_part.length > 0) {
-            lines.push(`### By CFR Part`);
-            for (const p of result.by_cfr_part) {
-                lines.push(`- **Part ${p.part}** — ${p.count}`);
+    });
+    server.tool("citation_analysis", "Analyze FDA citation patterns across warning letters. Break down by CFR part, section, category, and type. Identify CSA-relevant percentages. Powered by the enriched fda-csa-data dataset.", {
+        cfr_part: z.string().optional().describe("Filter by CFR part (e.g., '820', '211', '11')"),
+        category: z
+            .string()
+            .optional()
+            .describe("Filter by category (e.g., 'software_validation', 'design_controls', 'capa')"),
+        center: z.string().optional().describe("Filter by FDA center (e.g., 'CDRH', 'CDER')"),
+        fiscal_year: z.number().optional().describe("Filter by fiscal year (e.g., 2024, 2025)"),
+    }, async (params, extra) => {
+        const gate = await enrichedConnectionGate(extra.authInfo?.token);
+        if (!gate.ok)
+            return { content: gate.content };
+        try {
+            const result = await citationAnalysis(params);
+            if (!result) {
+                return { content: [{ type: "text", text: "No citation data found." }] };
             }
-            lines.push(``);
-        }
-        if (result.by_category.length > 0) {
-            lines.push(`### By Category`);
-            for (const c of result.by_category) {
-                const csa = c.csa_relevant ? " (CSA)" : "";
-                lines.push(`- **${c.category}** — ${c.count}${csa}`);
+            const filters = [
+                params.cfr_part && `CFR Part ${params.cfr_part}`,
+                params.category && `Category: ${params.category}`,
+                params.center && `Center: ${params.center}`,
+                params.fiscal_year && `FY${params.fiscal_year}`,
+            ]
+                .filter(Boolean)
+                .join(" | ");
+            const lines = [
+                `## FDA Citation Analysis`,
+                filters ? `**Filters:** ${filters}` : `**Scope:** All citations`,
+                `**Total:** ${result.total_citations} | **CSA-Relevant:** ${result.csa_percentage}%`,
+                ``,
+            ];
+            if (result.by_cfr_part.length > 0) {
+                lines.push(`### By CFR Part`);
+                for (const p of result.by_cfr_part) {
+                    lines.push(`- **Part ${p.part}** — ${p.count}`);
+                }
+                lines.push(``);
             }
-            lines.push(``);
-        }
-        if (result.top_sections.length > 0) {
-            lines.push(`### Top Sections`);
-            for (const s of result.top_sections) {
-                lines.push(`- **${s.cfr_full}** (${s.description}) — ${s.count}`);
+            if (result.by_category.length > 0) {
+                lines.push(`### By Category`);
+                for (const c of result.by_category) {
+                    const csa = c.csa_relevant ? " (CSA)" : "";
+                    lines.push(`- **${c.category}** — ${c.count}${csa}`);
+                }
+                lines.push(``);
             }
-            lines.push(``);
+            if (result.top_sections.length > 0) {
+                lines.push(`### Top Sections`);
+                for (const s of result.top_sections) {
+                    lines.push(`- **${s.cfr_full}** (${s.description}) — ${s.count}`);
+                }
+                lines.push(``);
+            }
+            return { content: [{ type: "text", text: lines.join("\n") }] };
         }
-        return { content: [{ type: "text", text: lines.join("\n") }] };
-    }
-    catch (error) {
-        return {
-            content: [
-                {
-                    type: "text",
-                    text: `Error: ${error instanceof Error ? error.message : String(error)}`,
-                },
-            ],
-            isError: true,
-        };
-    }
-});
-server.tool("supplier_qualification_report", "Generate an audit-ready supplier qualification report. Consolidates warning letters, 483 inspections, citations, failure modes, and CSA risk into a single brief with a qualification recommendation. Powered by the enriched fda-csa-data dataset.", {
-    company_name: z.string().describe("Supplier/company name to qualify"),
-}, async (params, extra) => {
-    const gate = await enrichedConnectionGate(extra.authInfo?.token);
-    if (!gate.ok)
-        return { content: gate.content };
-    try {
-        const result = await supplierQualification(params.company_name);
-        if (!result) {
+        catch (error) {
             return {
                 content: [
-                    { type: "text", text: `No data found for "${params.company_name}".` },
+                    {
+                        type: "text",
+                        text: `Error: ${error instanceof Error ? error.message : String(error)}`,
+                    },
                 ],
+                isError: true,
             };
         }
-        const lines = [
-            `## Supplier Qualification Report: ${result.company_name}`,
-            `*Generated ${new Date().toISOString().split("T")[0]}*`,
-            ``,
-        ];
-        if (result.csa_risk) {
-            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(``);
-        }
-        if (result.fei_numbers.length > 0) {
-            lines.push(`### Facility Establishment Identifiers (FEI)`);
-            for (const fei of result.fei_numbers) {
-                lines.push(`- ${fei}`);
+    });
+    server.tool("supplier_qualification_report", "Generate an audit-ready supplier qualification report. Consolidates warning letters, 483 inspections, citations, failure modes, and CSA risk into a single brief with a qualification recommendation. Powered by the enriched fda-csa-data dataset.", {
+        company_name: z.string().describe("Supplier/company name to qualify"),
+    }, async (params, extra) => {
+        const gate = await enrichedConnectionGate(extra.authInfo?.token);
+        if (!gate.ok)
+            return { content: gate.content };
+        try {
+            const result = await supplierQualification(params.company_name);
+            if (!result) {
+                return {
+                    content: [
+                        { type: "text", text: `No data found for "${params.company_name}".` },
+                    ],
+                };
             }
-            lines.push(``);
-        }
-        if (result.warning_letters.length > 0) {
-            lines.push(`### Warning Letters (${result.warning_letters.length})`);
-            lines.push(`| Date | Center | Regime | CSA |`);
-            lines.push(`|------|--------|--------|-----|`);
-            for (const wl of result.warning_letters) {
-                lines.push(`| ${wl.issue_date} | ${wl.center} | ${wl.regime} | ${wl.csa_relevant ? "YES" : "no"} |`);
+            const lines = [
+                `## Supplier Qualification Report: ${result.company_name}`,
+                `*Generated ${new Date().toISOString().split("T")[0]}*`,
+                ``,
+            ];
+            if (result.csa_risk) {
+                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 ${result.csa_risk.total_citations}`);
+                lines.push(``);
             }
-            lines.push(``);
-        }
-        if (result.inspections.length > 0) {
-            lines.push(`### Form 483 Inspections (${result.inspections.length})`);
-            lines.push(`| Date | Center | Area | CSA |`);
-            lines.push(`|------|--------|------|-----|`);
-            for (const insp of result.inspections) {
-                lines.push(`| ${insp.inspection_end_date} | ${insp.center} | ${insp.product_area} | ${insp.csa_relevant ? "YES" : "no"} |`);
+            if (result.fei_numbers.length > 0) {
+                lines.push(`### Facility Establishment Identifiers (FEI)`);
+                for (const fei of result.fei_numbers) {
+                    lines.push(`- ${fei}`);
+                }
+                lines.push(``);
             }
-            lines.push(``);
-        }
-        if (result.citation_summary.length > 0) {
-            lines.push(`### Citation Summary`);
-            for (const c of result.citation_summary) {
-                lines.push(`- **${c.cfr_full}** (${c.category}) — ${c.count}x`);
+            if (result.warning_letters.length > 0) {
+                lines.push(`### Warning Letters (${result.warning_letters.length})`);
+                lines.push(`| Date | Center | Regime | CSA |`);
+                lines.push(`|------|--------|--------|-----|`);
+                for (const wl of result.warning_letters) {
+                    lines.push(`| ${wl.issue_date} | ${wl.center} | ${wl.regime} | ${wl.csa_relevant ? "YES" : "no"} |`);
+                }
+                lines.push(``);
             }
-            lines.push(``);
-        }
-        if (result.failure_modes.length > 0) {
-            lines.push(`### Failure Modes`);
-            for (const fm of result.failure_modes) {
-                lines.push(`- **${fm.mode}** (confidence: ${fm.confidence}) — ${fm.count}x`);
+            if (result.inspections.length > 0) {
+                lines.push(`### Form 483 Inspections (${result.inspections.length})`);
+                lines.push(`| Date | Center | Area | CSA |`);
+                lines.push(`|------|--------|------|-----|`);
+                for (const insp of result.inspections) {
+                    lines.push(`| ${insp.inspection_end_date} | ${insp.center} | ${insp.product_area} | ${insp.csa_relevant ? "YES" : "no"} |`);
+                }
+                lines.push(``);
             }
-            lines.push(``);
+            if (result.citation_summary.length > 0) {
+                lines.push(`### Citation Summary`);
+                for (const c of result.citation_summary) {
+                    lines.push(`- **${c.cfr_full}** (${c.category}) — ${c.count}x`);
+                }
+                lines.push(``);
+            }
+            if (result.failure_modes.length > 0) {
+                lines.push(`### Failure Modes`);
+                for (const fm of result.failure_modes) {
+                    lines.push(`- **${fm.mode}** (confidence: ${fm.confidence}) — ${fm.count}x`);
+                }
+                lines.push(``);
+            }
+            if (result.csa_risk) {
+                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: lines.join("\n") }] };
         }
-        if (result.csa_risk) {
-            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.",
+        catch (error) {
+            return {
+                content: [
+                    {
+                        type: "text",
+                        text: `Error: ${error instanceof Error ? error.message : String(error)}`,
+                    },
+                ],
+                isError: true,
             };
-            lines.push(rec[result.csa_risk.risk_level] ?? "Insufficient data for recommendation.");
-            lines.push(``);
         }
-        return { content: [{ type: "text", text: lines.join("\n") }] };
-    }
-    catch (error) {
-        return {
-            content: [
-                {
-                    type: "text",
-                    text: `Error: ${error instanceof Error ? error.message : String(error)}`,
-                },
-            ],
-            isError: true,
-        };
-    }
-});
+    });
+} // end registerTools
 // ─── Start Server ────────────────────────────────────────────────────────────
 async function logStartup(mode) {
     const enriched = isEnrichedAvailable();
@@ -501,10 +509,8 @@ async function main() {
     const port = process.env.PORT;
     if (port) {
         // ─── HTTP mode (Railway deployment) ─────────────────────────
-        const transport = new WebStandardStreamableHTTPServerTransport({
-            sessionIdGenerator: () => crypto.randomUUID(),
-        });
-        await server.connect(transport);
+        // Per-session transport map: each client gets its own server + transport
+        const transports = new Map();
         Bun.serve({
             port: parseInt(port),
             async fetch(req) {
@@ -531,11 +537,33 @@ async function main() {
                     const token = authHeader?.startsWith("Bearer ")
                         ? authHeader.slice(7)
                         : undefined;
-                    return transport.handleRequest(req, {
-                        authInfo: token
-                            ? { token, clientId: "", scopes: [] }
-                            : undefined,
-                    });
+                    const authInfo = token
+                        ? { token, clientId: "", scopes: [] }
+                        : undefined;
+                    const sessionId = req.headers.get("mcp-session-id");
+                    // Existing session — route to its transport
+                    if (sessionId && transports.has(sessionId)) {
+                        return transports.get(sessionId).handleRequest(req, { authInfo });
+                    }
+                    // New session — create transport + server
+                    if (!sessionId && req.method === "POST") {
+                        const transport = new WebStandardStreamableHTTPServerTransport({
+                            sessionIdGenerator: () => crypto.randomUUID(),
+                            onsessioninitialized: (id) => {
+                                transports.set(id, transport);
+                            },
+                        });
+                        transport.onclose = () => {
+                            const sid = transport.sessionId;
+                            if (sid)
+                                transports.delete(sid);
+                        };
+                        const mcpServer = createServer();
+                        await mcpServer.connect(transport);
+                        return transport.handleRequest(req, { authInfo });
+                    }
+                    // Invalid — no session ID on non-init request
+                    return Response.json({ jsonrpc: "2.0", error: { code: -32000, message: "Bad Request: No valid session ID" }, id: null }, { status: 400 });
                 }
                 return new Response("Not found", { status: 404 });
             },
@@ -546,8 +574,9 @@ async function main() {
     }
     else {
         // ─── stdio mode (npx / local use) ───────────────────────────
+        stdioServer = createServer();
         const transport = new StdioServerTransport();
-        await server.connect(transport);
+        await stdioServer.connect(transport);
         await logStartup("stdio");
     }
 }

package/dist/index.js.map

@@ -1 +1 @@
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package/package.json

@@ -1,6 +1,6 @@
 {
   "name": "fda-mcp-server",
-  "version": "0.0.13",
+  "version": "0.0.14",
   "description": "MCP server for FDA Warning Letters, Form 483 Inspections, and Enforcement/Recall data. Query FDA public data from any MCP client.",
   "type": "module",
   "main": "dist/index.js",