fda-mcp-server 0.0.1

package/dist/index.js

@@ -0,0 +1,717 @@
+#!/usr/bin/env node
+/**
+ * FDA MCP Server
+ *
+ * MCP server exposing FDA Warning Letters, Form 483 Inspections,
+ * and Enforcement/Recall data as queryable tools.
+ *
+ * Data sources:
+ * - FDA.gov Warning Letters (Drupal/Solr DataTables)
+ * - FDA.gov FOIA 483 Inspection Observations
+ * - openFDA Enforcement (Recalls) API
+ */
+import { McpServer } from "@modelcontextprotocol/sdk/server/mcp.js";
+import { StdioServerTransport } from "@modelcontextprotocol/sdk/server/stdio.js";
+import { z } from "zod";
+import { searchWarningLetters, searchInspections, searchEnforcement, } from "./fda-client.js";
+import { isEnrichedAvailable, validateApiKey, testConnection, csaRiskAssessment, citationAnalysis, supplierQualification, } 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) {
+        return {
+            content: [
+                {
+                    type: "text",
+                    text: `Error searching warning letters: ${error instanceof Error ? error.message : String(error)}`,
+                },
+            ],
+            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.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") }],
+        };
+    }
+    catch (error) {
+        return {
+            content: [
+                {
+                    type: "text",
+                    text: `Error searching 483 inspections: ${error instanceof Error ? error.message : String(error)}`,
+                },
+            ],
+            isError: 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"),
+    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 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)"),
+}, 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.`,
+                    },
+                ],
+            };
+        }
+        const summary = [
+            `## FDA Enforcement Actions (Recalls)`,
+            `**Total results:** ${result.total}`,
+            `**Showing:** ${result.records.length} (skip ${params.skip ?? 0})`,
+            ``,
+        ];
+        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}`);
+            if (rec.product_description) {
+                const desc = rec.product_description.length > 200
+                    ? rec.product_description.substring(0, 200) + "..."
+                    : rec.product_description;
+                summary.push(`- **Product:** ${desc}`);
+            }
+            summary.push(`- **Distribution:** ${rec.distribution_pattern}`);
+            summary.push(``);
+        }
+        return {
+            content: [{ type: "text", text: summary.join("\n") }],
+        };
+    }
+    catch (error) {
+        return {
+            content: [
+                {
+                    type: "text",
+                    text: `Error searching recalls: ${error instanceof Error ? error.message : String(error)}`,
+                },
+            ],
+            isError: true,
+        };
+    }
+});
+// ─── 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"),
+    product_type: z
+        .enum(["drug", "device", "food"])
+        .optional()
+        .describe("Product type for recall search (default: drug)"),
+}, 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: [] })),
+            searchEnforcement({
+                recalling_firm: params.company_name,
+                product_type: params.product_type,
+                limit: 10,
+            }).catch(() => ({ total: 0, records: [] })),
+        ]);
+        const summary = [
+            `## 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}`);
+            }
+            summary.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}`);
+            }
+            summary.push(``);
+        }
+        if (recalls.records.length > 0) {
+            summary.push(`### Recalls (showing ${recalls.records.length})`);
+            for (const r of recalls.records) {
+                summary.push(`- **${r.recall_initiation_date}** | ${r.classification} | ${r.status} | ${r.reason_for_recall.substring(0, 120)}...`);
+            }
+            summary.push(``);
+        }
+        return {
+            content: [{ type: "text", text: summary.join("\n") }],
+        };
+    }
+    catch (error) {
+        return {
+            content: [
+                {
+                    type: "text",
+                    text: `Error building enforcement profile: ${error instanceof Error ? error.message : String(error)}`,
+                },
+            ],
+            isError: true,
+        };
+    }
+});
+// ─── 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"),
+}, 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 }],
+        };
+    }
+    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.`,
+                    },
+                ],
+            };
+        }
+        const summary = [
+            `## 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 (CSA findings on 483s are ${result.escalation_multiplier}x more likely to become warning letters)`,
+            ``,
+        ];
+        if (result.top_cfr_citations.length > 0) {
+            summary.push(`### Top CFR Citations`);
+            for (const c of result.top_cfr_citations) {
+                summary.push(`- **${c.cfr_full}** (${c.category}) — ${c.count} citations`);
+            }
+            summary.push(``);
+        }
+        if (result.failure_modes.length > 0) {
+            summary.push(`### Identified Failure Modes`);
+            for (const fm of result.failure_modes) {
+                summary.push(`- ${fm}`);
+            }
+            summary.push(``);
+        }
+        return {
+            content: [{ type: "text", text: summary.join("\n") }],
+        };
+    }
+    catch (error) {
+        return {
+            content: [
+                {
+                    type: "text",
+                    text: `Error running CSA risk assessment: ${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')"),
+    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)"),
+}, 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 }],
+        };
+    }
+    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.`,
+                    },
+                ],
+            };
+        }
+        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 summary = [
+            `## FDA Citation Analysis`,
+            filters ? `**Filters:** ${filters}` : `**Scope:** All citations`,
+            `**Total Citations:** ${result.total_citations}`,
+            `**CSA-Relevant:** ${result.csa_percentage}%`,
+            ``,
+        ];
+        if (result.by_cfr_part.length > 0) {
+            summary.push(`### By CFR Part`);
+            for (const p of result.by_cfr_part) {
+                summary.push(`- **Part ${p.part}** — ${p.count} citations`);
+            }
+            summary.push(``);
+        }
+        if (result.by_category.length > 0) {
+            summary.push(`### By Category`);
+            for (const c of result.by_category) {
+                const csa = c.csa_relevant ? " ⚠ CSA" : "";
+                summary.push(`- **${c.category}** — ${c.count}${csa}`);
+            }
+            summary.push(``);
+        }
+        if (result.top_sections.length > 0) {
+            summary.push(`### Top CFR Sections`);
+            for (const s of result.top_sections) {
+                summary.push(`- **${s.cfr_full}** (${s.description}) — ${s.count}`);
+            }
+            summary.push(``);
+        }
+        if (result.by_type.length > 0) {
+            summary.push(`### By Citation Type`);
+            for (const t of result.by_type) {
+                summary.push(`- **${t.type}** — ${t.count}`);
+            }
+            summary.push(``);
+        }
+        return {
+            content: [{ type: "text", text: summary.join("\n") }],
+        };
+    }
+    catch (error) {
+        return {
+            content: [
+                {
+                    type: "text",
+                    text: `Error running citation analysis: ${error instanceof Error ? error.message : String(error)}`,
+                },
+            ],
+            isError: true,
+        };
+    }
+});
+// Tool: supplier_qualification_report
+server.tool("supplier_qualification_report", "Generate a comprehensive supplier qualification report for FDA-regulated supplier assessments. Consolidates warning letters, 483 inspections, citations, failure modes, and CSA risk into a single audit-ready brief. Requires DATABASE_URL environment variable.", {
+    company_name: z
+        .string()
+        .describe("Supplier/company name to qualify"),
+}, async (params) => {
+    if (!isEnrichedAvailable()) {
+        return {
+            content: [
+                {
+                    type: "text",
+                    text: `Supplier qualification report requires the enriched dataset. Set DATABASE_URL to your fda-csa-data PostgreSQL instance.\n\nSee: https://github.com/jasencarroll/fda-csa-data\n\nFor a lighter-weight alternative, use the \`company_enforcement_profile\` tool.`,
+                },
+            ],
+        };
+    }
+    const auth = validateApiKey();
+    if (!auth.valid) {
+        return {
+            content: [{ type: "text", text: auth.message }],
+        };
+    }
+    try {
+        const connected = await testConnection();
+        if (!connected) {
+            return {
+                content: [
+                    {
+                        type: "text",
+                        text: `Could not connect to the fda-csa-data database. Check your DATABASE_URL.`,
+                    },
+                ],
+                isError: true,
+            };
+        }
+        const result = await supplierQualification(params.company_name);
+        if (!result) {
+            return {
+                content: [
+                    {
+                        type: "text",
+                        text: `No data found for "${params.company_name}" in the enriched dataset.`,
+                    },
+                ],
+            };
+        }
+        const summary = [
+            `## 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(``);
+        }
+        // FEI numbers
+        if (result.fei_numbers.length > 0) {
+            summary.push(`### Facility Establishment Identifiers (FEI)`);
+            for (const fei of result.fei_numbers) {
+                summary.push(`- ${fei}`);
+            }
+            summary.push(``);
+        }
+        // Warning letters
+        if (result.warning_letters.length > 0) {
+            summary.push(`### Warning Letters (${result.warning_letters.length})`);
+            summary.push(`| Date | Center | Regime | CSA |`);
+            summary.push(`|------|--------|--------|-----|`);
+            for (const wl of result.warning_letters) {
+                summary.push(`| ${wl.issue_date} | ${wl.center} | ${wl.regime} | ${wl.csa_relevant ? "YES" : "no"} |`);
+            }
+            summary.push(``);
+        }
+        // Inspections
+        if (result.inspections.length > 0) {
+            summary.push(`### Form 483 Inspections (${result.inspections.length})`);
+            summary.push(`| Date | Center | Area | CSA |`);
+            summary.push(`|------|--------|------|-----|`);
+            for (const insp of result.inspections) {
+                summary.push(`| ${insp.inspection_end_date} | ${insp.center} | ${insp.product_area} | ${insp.csa_relevant ? "YES" : "no"} |`);
+            }
+            summary.push(``);
+        }
+        // Citations
+        if (result.citation_summary.length > 0) {
+            summary.push(`### Citation Summary`);
+            for (const c of result.citation_summary) {
+                summary.push(`- **${c.cfr_full}** (${c.category}) — ${c.count}x`);
+            }
+            summary.push(``);
+        }
+        // Failure modes
+        if (result.failure_modes.length > 0) {
+            summary.push(`### Identified Failure Modes`);
+            for (const fm of result.failure_modes) {
+                summary.push(`- **${fm.mode}** (${fm.confidence} confidence) — ${fm.count}x`);
+            }
+            summary.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(``);
+        }
+        return {
+            content: [{ type: "text", text: summary.join("\n") }],
+        };
+    }
+    catch (error) {
+        return {
+            content: [
+                {
+                    type: "text",
+                    text: `Error generating supplier qualification report: ${error instanceof Error ? error.message : String(error)}`,
+                },
+            ],
+            isError: true,
+        };
+    }
+});
+// ─── Start Server ────────────────────────────────────────────────────────────
+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`);
+    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`);
+        }
+    }
+    else {
+        console.error(`  Enriched tools: INACTIVE (set DATABASE_URL to enable)`);
+    }
+}
+main().catch((error) => {
+    console.error("Fatal error:", error);
+    process.exit(1);
+});
+//# sourceMappingURL=index.js.map