fda-mcp-server 0.0.6 → 0.0.8

package/dist/db.d.ts

@@ -18,12 +18,16 @@ export declare function getPool(): pg.Pool | null;
 export declare function isEnrichedAvailable(): boolean;
 /**
  * Validate API key for enriched tool access.
- * If FDA_MCP_API_KEY is set on the server, FDA_API_KEY must match.
- * If FDA_MCP_API_KEY is not set, access is open (local dev mode).
+ *
+ * Supports two modes:
+ * 1. HMAC-signed keys (fda_live_<payload>.<sig>) — validated with FDA_KEY_SECRET
+ * 2. Legacy simple match — FDA_API_KEY === FDA_MCP_API_KEY
+ * 3. No secret set — open access (local dev mode)
  */
 export declare function validateApiKey(): {
     valid: boolean;
     message?: string;
+    tier?: string;
 };
 export declare function testConnection(): Promise<boolean>;
 export interface CSARiskResult {
@@ -101,5 +105,23 @@ export interface SupplierQualResult {
     }[];
     csa_risk: CSARiskResult | null;
 }
+export interface CompanyEnrichedResult {
+    warning_letters: {
+        issue_date: string;
+        center: string;
+        regime: string;
+        csa_relevant: boolean;
+        subject: string;
+    }[];
+    inspections: {
+        inspection_date: string;
+        center: string;
+        product_area: string;
+        csa_relevant: boolean;
+    }[];
+    total_warning_letters: number;
+    total_inspections: number;
+}
+export declare function companyEnrichedProfile(companyName: string): Promise<CompanyEnrichedResult | null>;
 export declare function supplierQualification(companyName: string): Promise<SupplierQualResult | null>;
 //# sourceMappingURL=db.d.ts.map

package/dist/db.d.ts.map

@@ -1 +1 @@
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+{"version":3,"file":"db.d.ts","sourceRoot":"","sources":["../src/db.ts"],"names":[],"mappings":"AAAA;;;;;;;;;;;;;;GAcG;AAGH,OAAO,EAAE,MAAM,IAAI,CAAC;AAKpB,wBAAgB,OAAO,IAAI,EAAE,CAAC,IAAI,GAAG,IAAI,CAkBxC;AAED,wBAAgB,mBAAmB,IAAI,OAAO,CAE7C;AAED;;;;;;;GAOG;AACH,wBAAgB,cAAc,IAAI;IAChC,KAAK,EAAE,OAAO,CAAC;IACf,OAAO,CAAC,EAAE,MAAM,CAAC;IACjB,IAAI,CAAC,EAAE,MAAM,CAAC;CACf,CA4EA;AAED,wBAAsB,cAAc,IAAI,OAAO,CAAC,OAAO,CAAC,CASvD;AAID,MAAM,WAAW,aAAa;IAC5B,YAAY,EAAE,MAAM,CAAC;IACrB,oBAAoB,EAAE,MAAM,CAAC;IAC7B,wBAAwB,EAAE,MAAM,CAAC;IACjC,eAAe,EAAE,MAAM,CAAC;IACxB,aAAa,EAAE,MAAM,CAAC;IACtB,gBAAgB,EAAE,MAAM,CAAC;IACzB,oBAAoB,EAAE,MAAM,CAAC;IAC7B,aAAa,EAAE,MAAM,EAAE,CAAC;IACxB,iBAAiB,EAAE;QAAE,QAAQ,EAAE,MAAM,CAAC;QAAC,QAAQ,EAAE,MAAM,CAAC;QAAC,KAAK,EAAE,MAAM,CAAA;KAAE,EAAE,CAAC;IAC3E,UAAU,EAAE,MAAM,CAAC;IACnB,UAAU,EAAE,KAAK,GAAG,UAAU,GAAG,MAAM,GAAG,UAAU,CAAC;IACrD,qBAAqB,EAAE,MAAM,CAAC;CAC/B;AAED,wBAAsB,iBAAiB,CACrC,WAAW,EAAE,MAAM,GAClB,OAAO,CAAC,aAAa,GAAG,IAAI,CAAC,CAoG/B;AAED,MAAM,WAAW,sBAAsB;IACrC,eAAe,EAAE,MAAM,CAAC;IACxB,OAAO,EAAE;QAAE,IAAI,EAAE,MAAM,CAAC;QAAC,KAAK,EAAE,MAAM,CAAA;KAAE,EAAE,CAAC;IAC3C,WAAW,EAAE;QAAE,IAAI,EAAE,MAAM,CAAC;QAAC,KAAK,EAAE,MAAM,CAAA;KAAE,EAAE,CAAC;IAC/C,WAAW,EAAE;QAAE,QAAQ,EAAE,MAAM,CAAC;QAAC,KAAK,EAAE,MAAM,CAAC;QAAC,YAAY,EAAE,OAAO,CAAA;KAAE,EAAE,CAAC;IAC1E,YAAY,EAAE;QAAE,QAAQ,EAAE,MAAM,CAAC;QAAC,WAAW,EAAE,MAAM,CAAC;QAAC,KAAK,EAAE,MAAM,CAAA;KAAE,EAAE,CAAC;IACzE,cAAc,EAAE,MAAM,CAAC;CACxB;AAED,wBAAsB,gBAAgB,CAAC,MAAM,EAAE;IAC7C,QAAQ,CAAC,EAAE,MAAM,CAAC;IAClB,QAAQ,CAAC,EAAE,MAAM,CAAC;IAClB,MAAM,CAAC,EAAE,MAAM,CAAC;IAChB,WAAW,CAAC,EAAE,MAAM,CAAC;CACtB,GAAG,OAAO,CAAC,sBAAsB,GAAG,IAAI,CAAC,CAqFzC;AAED,MAAM,WAAW,kBAAkB;IACjC,YAAY,EAAE,MAAM,CAAC;IACrB,WAAW,EAAE,MAAM,EAAE,CAAC;IACtB,eAAe,EAAE;QACf,UAAU,EAAE,MAAM,CAAC;QACnB,MAAM,EAAE,MAAM,CAAC;QACf,MAAM,EAAE,MAAM,CAAC;QACf,YAAY,EAAE,OAAO,CAAC;QACtB,GAAG,EAAE,MAAM,CAAC;KACb,EAAE,CAAC;IACJ,WAAW,EAAE;QACX,mBAAmB,EAAE,MAAM,CAAC;QAC5B,MAAM,EAAE,MAAM,CAAC;QACf,YAAY,EAAE,MAAM,CAAC;QACrB,YAAY,EAAE,OAAO,CAAC;KACvB,EAAE,CAAC;IACJ,gBAAgB,EAAE;QAAE,QAAQ,EAAE,MAAM,CAAC;QAAC,QAAQ,EAAE,MAAM,CAAC;QAAC,KAAK,EAAE,MAAM,CAAA;KAAE,EAAE,CAAC;IAC1E,aAAa,EAAE;QAAE,IAAI,EAAE,MAAM,CAAC;QAAC,UAAU,EAAE,MAAM,CAAC;QAAC,KAAK,EAAE,MAAM,CAAA;KAAE,EAAE,CAAC;IACrE,QAAQ,EAAE,aAAa,GAAG,IAAI,CAAC;CAChC;AAED,MAAM,WAAW,qBAAqB;IACpC,eAAe,EAAE;QACf,UAAU,EAAE,MAAM,CAAC;QACnB,MAAM,EAAE,MAAM,CAAC;QACf,MAAM,EAAE,MAAM,CAAC;QACf,YAAY,EAAE,OAAO,CAAC;QACtB,OAAO,EAAE,MAAM,CAAC;KACjB,EAAE,CAAC;IACJ,WAAW,EAAE;QACX,eAAe,EAAE,MAAM,CAAC;QACxB,MAAM,EAAE,MAAM,CAAC;QACf,YAAY,EAAE,MAAM,CAAC;QACrB,YAAY,EAAE,OAAO,CAAC;KACvB,EAAE,CAAC;IACJ,qBAAqB,EAAE,MAAM,CAAC;IAC9B,iBAAiB,EAAE,MAAM,CAAC;CAC3B;AAED,wBAAsB,sBAAsB,CAC1C,WAAW,EAAE,MAAM,GAClB,OAAO,CAAC,qBAAqB,GAAG,IAAI,CAAC,CAyDvC;AAED,wBAAsB,qBAAqB,CACzC,WAAW,EAAE,MAAM,GAClB,OAAO,CAAC,kBAAkB,GAAG,IAAI,CAAC,CAgGpC"}

package/dist/db.js

@@ -13,6 +13,7 @@
  *
  * Schema: github.com/jasencarroll/fda-csa-data
  */
+import crypto from "node:crypto";
 import pg from "pg";
 const { Pool } = pg;
 let pool = null;
@@ -38,27 +39,74 @@ export function isEnrichedAvailable() {
 }
 /**
  * Validate API key for enriched tool access.
- * If FDA_MCP_API_KEY is set on the server, FDA_API_KEY must match.
- * If FDA_MCP_API_KEY is not set, access is open (local dev mode).
+ *
+ * Supports two modes:
+ * 1. HMAC-signed keys (fda_live_<payload>.<sig>) — validated with FDA_KEY_SECRET
+ * 2. Legacy simple match — FDA_API_KEY === FDA_MCP_API_KEY
+ * 3. No secret set — open access (local dev mode)
  */
 export function validateApiKey() {
-    const serverKey = process.env.FDA_MCP_API_KEY;
-    if (!serverKey)
-        return { valid: true }; // no key required (local mode)
+    const hmacSecret = process.env.FDA_KEY_SECRET;
+    const legacyKey = process.env.FDA_MCP_API_KEY;
+    // No secrets configured — open access (local/dev)
+    if (!hmacSecret && !legacyKey)
+        return { valid: true };
     const clientKey = process.env.FDA_API_KEY;
     if (!clientKey) {
         return {
             valid: false,
-            message: "Enriched tools require an API key. Set FDA_API_KEY in your MCP client config.\n\nGet a key at: https://jasenc.dev/fda-mcp",
+            message: "Enriched tools require an API key. Set FDA_API_KEY in your MCP client config.\n\nGet a key at: https://fda-mcp.jasencarroll.com",
         };
     }
-    if (clientKey !== serverKey) {
-        return {
-            valid: false,
-            message: "Invalid API key. Check your FDA_API_KEY value.",
-        };
+    // HMAC-signed key validation
+    if (hmacSecret && clientKey.startsWith("fda_live_")) {
+        const body = clientKey.slice("fda_live_".length);
+        const dotIndex = body.indexOf(".");
+        if (dotIndex === -1) {
+            return { valid: false, message: "Invalid API key format." };
+        }
+        const payloadB64 = body.slice(0, dotIndex);
+        const sigB64 = body.slice(dotIndex + 1);
+        try {
+            const payloadBytes = Buffer.from(payloadB64, "base64url");
+            const expectedSig = crypto
+                .createHmac("sha256", hmacSecret)
+                .update(payloadBytes)
+                .digest();
+            const actualSig = Buffer.from(sigB64, "base64url");
+            if (expectedSig.length !== actualSig.length ||
+                !crypto.timingSafeEqual(expectedSig, actualSig)) {
+                return { valid: false, message: "Invalid API key." };
+            }
+            const payload = JSON.parse(payloadBytes.toString("utf-8"));
+            if (payload.exp && payload.exp < Math.floor(Date.now() / 1000)) {
+                return {
+                    valid: false,
+                    message: "API key expired. Renew at https://fda-mcp.jasencarroll.com",
+                };
+            }
+            // Optional blocklist check
+            const blocklist = process.env.FDA_KEY_BLOCKLIST;
+            if (blocklist) {
+                const hash = crypto
+                    .createHash("sha256")
+                    .update(clientKey)
+                    .digest("hex");
+                if (blocklist.split(",").includes(hash)) {
+                    return { valid: false, message: "API key has been revoked." };
+                }
+            }
+            return { valid: true, tier: payload.tier };
+        }
+        catch {
+            return { valid: false, message: "Invalid API key." };
+        }
     }
-    return { valid: true };
+    // Legacy simple key match
+    if (legacyKey && clientKey === legacyKey) {
+        return { valid: true };
+    }
+    return { valid: false, message: "Invalid API key." };
 }
 export async function testConnection() {
     const p = getPool();
@@ -93,7 +141,7 @@ export async function csaRiskAssessment(companyName) {
      JOIN warning_letter wl ON c.letter_id = wl.id
      WHERE LOWER(wl.company_name) LIKE LOWER($1)`, [`%${companyName}%`]);
     // Top CFR citations
-    const topCfr = await p.query(`SELECT c.cfr_full, c.normalized_category, COUNT(*) AS cnt
+    const topCfr = await p.query(`SELECT COALESCE(c.cfr_full, 'N/A') AS cfr_full, c.normalized_category, COUNT(*) AS cnt
      FROM citation c
      JOIN warning_letter wl ON c.letter_id = wl.id
      WHERE LOWER(wl.company_name) LIKE LOWER($1)
@@ -180,7 +228,7 @@ export async function citationAnalysis(params) {
     const byType = await p.query(`SELECT c.citation_type AS type, COUNT(*) AS cnt
      FROM citation c JOIN warning_letter wl ON c.letter_id = wl.id ${where}
      GROUP BY c.citation_type ORDER BY cnt DESC`, values);
-    const byPart = await p.query(`SELECT c.cfr_part AS part, COUNT(*) AS cnt
+    const byPart = await p.query(`SELECT COALESCE(c.cfr_part::text, 'N/A') AS part, COUNT(*) AS cnt
      FROM citation c JOIN warning_letter wl ON c.letter_id = wl.id ${where}
      GROUP BY c.cfr_part ORDER BY cnt DESC LIMIT 15`, values);
     const byCategory = await p.query(`SELECT c.normalized_category AS category, COUNT(*) AS cnt,
@@ -190,7 +238,7 @@ export async function citationAnalysis(params) {
        ) THEN true ELSE false END AS csa_relevant
      FROM citation c JOIN warning_letter wl ON c.letter_id = wl.id ${where}
      GROUP BY c.normalized_category ORDER BY cnt DESC`, values);
-    const topSections = await p.query(`SELECT c.cfr_full, c.normalized_category AS description, COUNT(*) AS cnt
+    const topSections = await p.query(`SELECT COALESCE(c.cfr_full, 'N/A') AS cfr_full, c.normalized_category AS description, COUNT(*) AS cnt
      FROM citation c JOIN warning_letter wl ON c.letter_id = wl.id ${where}
      GROUP BY c.cfr_full, c.normalized_category ORDER BY cnt DESC LIMIT 20`, values);
     const total = parseInt(totalResult.rows[0]?.total ?? "0");
@@ -214,6 +262,48 @@ export async function citationAnalysis(params) {
         csa_percentage: total > 0 ? Math.round((csaCount / total) * 100 * 10) / 10 : 0,
     };
 }
+export async function companyEnrichedProfile(companyName) {
+    const p = getPool();
+    if (!p)
+        return null;
+    const wlResult = await p.query(`SELECT
+       to_char(to_timestamp(issue_date), 'YYYY-MM-DD') AS issue_date,
+       center, regime, csa_relevant,
+       COALESCE(letter_subject, '') AS subject
+     FROM warning_letter
+     WHERE LOWER(company_name) LIKE LOWER($1)
+     ORDER BY issue_date DESC
+     LIMIT 10`, [`%${companyName}%`]);
+    const wlCount = await p.query(`SELECT COUNT(*) AS cnt FROM warning_letter WHERE LOWER(company_name) LIKE LOWER($1)`, [`%${companyName}%`]);
+    const inspResult = await p.query(`SELECT
+       CASE WHEN inspection_end_date IS NOT NULL
+         THEN to_char(to_timestamp(inspection_end_date), 'YYYY-MM-DD')
+         ELSE ''
+       END AS inspection_date,
+       center, product_area, csa_relevant
+     FROM observation_483
+     WHERE LOWER(company_name) LIKE LOWER($1)
+     ORDER BY inspection_end_date DESC
+     LIMIT 10`, [`%${companyName}%`]);
+    const inspCount = await p.query(`SELECT COUNT(*) AS cnt FROM observation_483 WHERE LOWER(company_name) LIKE LOWER($1)`, [`%${companyName}%`]);
+    return {
+        warning_letters: wlResult.rows.map((r) => ({
+            issue_date: r.issue_date ?? "",
+            center: r.center ?? "",
+            regime: r.regime ?? "",
+            csa_relevant: r.csa_relevant ?? false,
+            subject: r.subject ?? "",
+        })),
+        inspections: inspResult.rows.map((r) => ({
+            inspection_date: r.inspection_date ?? "",
+            center: r.center ?? "",
+            product_area: r.product_area ?? "",
+            csa_relevant: r.csa_relevant ?? false,
+        })),
+        total_warning_letters: parseInt(wlCount.rows[0]?.cnt ?? "0"),
+        total_inspections: parseInt(inspCount.rows[0]?.cnt ?? "0"),
+    };
+}
 export async function supplierQualification(companyName) {
     const p = getPool();
     if (!p)
@@ -232,14 +322,19 @@ export async function supplierQualification(companyName) {
      WHERE LOWER(company_name) LIKE LOWER($1)
      ORDER BY issue_date DESC
      LIMIT 20`, [`%${companyName}%`]);
-    // 483 inspections
-    const inspResult = await p.query(`SELECT inspection_end_date, center, product_area, csa_relevant
+    // 483 inspections (inspection_end_date is stored as Unix epoch)
+    const inspResult = await p.query(`SELECT
+       CASE WHEN inspection_end_date IS NOT NULL
+         THEN to_char(to_timestamp(inspection_end_date), 'YYYY-MM-DD')
+         ELSE ''
+       END AS inspection_date,
+       center, product_area, csa_relevant
      FROM observation_483
      WHERE LOWER(company_name) LIKE LOWER($1)
      ORDER BY inspection_end_date DESC
      LIMIT 20`, [`%${companyName}%`]);
     // Citation summary
-    const citResult = await p.query(`SELECT c.cfr_full, c.normalized_category, COUNT(*) AS cnt
+    const citResult = await p.query(`SELECT COALESCE(c.cfr_full, 'N/A') AS cfr_full, c.normalized_category, COUNT(*) AS cnt
      FROM citation c
      JOIN warning_letter wl ON c.letter_id = wl.id
      WHERE LOWER(wl.company_name) LIKE LOWER($1)
@@ -267,7 +362,7 @@ export async function supplierQualification(companyName) {
             url: r.url ?? "",
         })),
         inspections: inspResult.rows.map((r) => ({
-            inspection_end_date: r.inspection_end_date ?? "",
+            inspection_end_date: r.inspection_date ?? "",
             center: r.center ?? "",
             product_area: r.product_area ?? "",
             csa_relevant: r.csa_relevant ?? false,

package/dist/db.js.map

@@ -1 +1 @@
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package/dist/fda-client.d.ts

@@ -1,22 +1,10 @@
 /**
- * FDA API Client
+ * openFDA API Client
  *
- * Wraps FDA public data sources:
- * 1. FDA.gov Warning Letters (Drupal DataTables / Solr)
- * 2. FDA.gov 483 Inspection Observations (FOIA Reading Room)
- * 3. openFDA Enforcement/Recalls API
+ * Wraps public openFDA data sources:
+ * 1. Enforcement/Recalls (drug, device, food)
+ * 2. Device Adverse Events (MAUDE database)
  */
-export interface WarningLetter {
-    posted_date: string;
-    issue_date: string;
-    company_name: string;
-    issuing_office: string;
-    subject: string;
-    response_letter: string;
-    closeout_letter: string;
-    excerpt: string;
-    url: string;
-}
 export interface EnforcementRecord {
     recall_number: string;
     status: string;
@@ -37,58 +25,45 @@ export interface EnforcementRecord {
     termination_date: string;
     event_id: string;
 }
-export interface InspectionRecord {
-    firm_name: string;
-    fei_number: string;
-    city: string;
-    state: string;
-    country: string;
-    zip_code: string;
-    inspection_end_date: string;
-    classification: string;
-    center: string;
-    project_area: string;
-    posted_citations: string;
-    url?: string;
+export interface DeviceEventRecord {
+    report_number: string;
+    event_type: string;
+    date_received: string;
+    date_of_event: string;
+    device_name: string;
+    manufacturer: string;
+    brand_name: string;
+    product_code: string;
+    event_description: string;
+    patient_outcome: string[];
+    device_class: string;
 }
-export declare function searchWarningLetters(params: {
+export declare function searchEnforcement(params: {
     search?: string;
-    issuing_office?: string;
-    limit?: number;
-    offset?: number;
-    date_from?: string;
-    date_to?: string;
-}): Promise<{
-    total: number;
-    letters: WarningLetter[];
-}>;
-export declare function get483XlsxUrls(): Record<string, string>;
-export declare function searchInspections(params: {
-    firm_name?: string;
+    product_type?: "drug" | "device" | "food";
+    classification?: "Class I" | "Class II" | "Class III";
     state?: string;
-    center?: string;
-    project_area?: string;
-    limit?: number;
-    offset?: number;
+    recalling_firm?: string;
     date_from?: string;
     date_to?: string;
+    limit?: number;
+    skip?: number;
 }): Promise<{
     total: number;
-    inspections: InspectionRecord[];
-    note?: string;
+    records: EnforcementRecord[];
 }>;
-export declare function searchEnforcement(params: {
+export declare function searchDeviceEvents(params: {
     search?: string;
-    product_type?: "drug" | "device" | "food";
-    classification?: "Class I" | "Class II" | "Class III";
-    state?: string;
-    recalling_firm?: string;
+    manufacturer?: string;
+    brand_name?: string;
+    event_type?: "Injury" | "Malfunction" | "Death" | "Other";
+    product_code?: string;
     date_from?: string;
     date_to?: string;
     limit?: number;
     skip?: number;
 }): Promise<{
     total: number;
-    records: EnforcementRecord[];
+    events: DeviceEventRecord[];
 }>;
 //# sourceMappingURL=fda-client.d.ts.map

package/dist/fda-client.d.ts.map

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