fda-mcp-server 0.0.15 → 0.0.17

package/README.md

@@ -67,7 +67,7 @@ Restart your client. You should see `search_recalls`, `search_device_events`, an
 
 ### Pro (hosted, all 6 tools)
 
-Get an API key at [fda-mcp.jasencarroll.com](https://fda-mcp.jasencarroll.com). Pro connects to the hosted server over HTTP — no npm install needed.
+Get an API key at [fda-csa-intel.jasencarroll.com](https://fda-csa-intel.jasencarroll.com). Pro connects to the hosted server over HTTP — no npm install needed.
 
 **Claude Desktop** — add to `Settings > Developer > Edit Config`:
 
@@ -102,7 +102,7 @@ The server supports two transports:
 
 Free tools use live public data from the [openFDA API](https://open.fda.gov/) (recalls, adverse events). No authentication required.
 
-Pro tools query a curated PostgreSQL database classifying FDA warning letters and 483 observations for CSA relevance based on CFR citations (21 CFR 211.68, 820.70(i), Part 11) and narrative analysis. Dataset maintained at [fda-csa-data](https://github.com/jasencarroll/fda-csa-data).
+Pro tools query a curated PostgreSQL database classifying FDA warning letters and 483 observations for CSA relevance based on CFR citations (21 CFR 211.68, 820.70(i), Part 11) and narrative analysis. Dataset maintained at [fda_platform](https://github.com/jasencarroll/fda_platform).
 
 ## Self-Hosting
 
@@ -115,14 +115,14 @@ Run enriched tools against your own database instead of using an API key:
       "command": "npx",
       "args": ["-y", "fda-mcp-server"],
       "env": {
-        "DATABASE_URL": "postgresql://localhost:5432/fda-csa-data"
+        "DATABASE_URL": "postgresql://localhost:5432/fda_platform"
       }
     }
   }
 }
 ```
 
-See [fda-csa-data](https://github.com/jasencarroll/fda-csa-data) for the database dump and restore instructions.
+See [fda_platform](https://github.com/jasencarroll/fda_platform) for the database dump and restore instructions.
 
 ## License
 
@@ -131,3 +131,4 @@ MIT
 ## Author
 
 [Jasen Carroll](https://jasencarroll.com) — Quality engineering + software, FDA-regulated industries.
+

package/dist/db.d.ts

@@ -105,6 +105,28 @@ export interface SupplierQualResult {
     }[];
     csa_risk: CSARiskResult | null;
 }
+export interface ConsentDecreeResult {
+    id: string;
+    company_name: string;
+    issue_date: string | null;
+    court: string | null;
+    docket_number: string | null;
+    terms_summary: string | null;
+    csa_relevant: boolean;
+    fei_number: string | null;
+    source_url: string;
+}
+export interface ConsentDecreeSearchResult {
+    total: number;
+    decrees: ConsentDecreeResult[];
+}
+export declare function searchConsentDecrees(params: {
+    company_name?: string;
+    date_from?: string;
+    date_to?: string;
+    csa_relevant?: boolean;
+    limit?: number;
+}): Promise<ConsentDecreeSearchResult | null>;
 export interface CompanyEnrichedResult {
     warning_letters: {
         issue_date: string;
@@ -119,8 +141,16 @@ export interface CompanyEnrichedResult {
         product_area: string;
         csa_relevant: boolean;
     }[];
+    consent_decrees: {
+        issue_date: string | null;
+        court: string | null;
+        terms_summary: string | null;
+        csa_relevant: boolean;
+        source_url: string;
+    }[];
     total_warning_letters: number;
     total_inspections: number;
+    total_consent_decrees: number;
 }
 export declare function companyEnrichedProfile(companyName: string): Promise<CompanyEnrichedResult | null>;
 export declare function supplierQualification(companyName: string): Promise<SupplierQualResult | null>;

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,CAAC,iBAAiB,CAAC,EAAE,MAAM,GAAG;IAC1D,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,mBAAmB;IAClC,EAAE,EAAE,MAAM,CAAC;IACX,YAAY,EAAE,MAAM,CAAC;IACrB,UAAU,EAAE,MAAM,GAAG,IAAI,CAAC;IAC1B,KAAK,EAAE,MAAM,GAAG,IAAI,CAAC;IACrB,aAAa,EAAE,MAAM,GAAG,IAAI,CAAC;IAC7B,aAAa,EAAE,MAAM,GAAG,IAAI,CAAC;IAC7B,YAAY,EAAE,OAAO,CAAC;IACtB,UAAU,EAAE,MAAM,GAAG,IAAI,CAAC;IAC1B,UAAU,EAAE,MAAM,CAAC;CACpB;AAED,MAAM,WAAW,yBAAyB;IACxC,KAAK,EAAE,MAAM,CAAC;IACd,OAAO,EAAE,mBAAmB,EAAE,CAAC;CAChC;AAED,wBAAsB,oBAAoB,CAAC,MAAM,EAAE;IACjD,YAAY,CAAC,EAAE,MAAM,CAAC;IACtB,SAAS,CAAC,EAAE,MAAM,CAAC;IACnB,OAAO,CAAC,EAAE,MAAM,CAAC;IACjB,YAAY,CAAC,EAAE,OAAO,CAAC;IACvB,KAAK,CAAC,EAAE,MAAM,CAAC;CAChB,GAAG,OAAO,CAAC,yBAAyB,GAAG,IAAI,CAAC,CA8D5C;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,eAAe,EAAE;QACf,UAAU,EAAE,MAAM,GAAG,IAAI,CAAC;QAC1B,KAAK,EAAE,MAAM,GAAG,IAAI,CAAC;QACrB,aAAa,EAAE,MAAM,GAAG,IAAI,CAAC;QAC7B,YAAY,EAAE,OAAO,CAAC;QACtB,UAAU,EAAE,MAAM,CAAC;KACpB,EAAE,CAAC;IACJ,qBAAqB,EAAE,MAAM,CAAC;IAC9B,iBAAiB,EAAE,MAAM,CAAC;IAC1B,qBAAqB,EAAE,MAAM,CAAC;CAC/B;AAED,wBAAsB,sBAAsB,CAC1C,WAAW,EAAE,MAAM,GAClB,OAAO,CAAC,qBAAqB,GAAG,IAAI,CAAC,CAkFvC;AAED,wBAAsB,qBAAqB,CACzC,WAAW,EAAE,MAAM,GAClB,OAAO,CAAC,kBAAkB,GAAG,IAAI,CAAC,CAgGpC"}

package/dist/db.js

@@ -55,7 +55,7 @@ export function validateApiKey(clientKeyOverride) {
     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://fda-mcp.jasencarroll.com",
+            message: "Enriched tools require an API key. Set FDA_API_KEY in your MCP client config.\n\nGet a key at: https://fda-csa-intel.jasencarroll.com",
         };
     }
     // HMAC-signed key validation
@@ -82,7 +82,7 @@ export function validateApiKey(clientKeyOverride) {
             if (payload.exp && payload.exp < Math.floor(Date.now() / 1000)) {
                 return {
                     valid: false,
-                    message: "API key expired. Renew at https://fda-mcp.jasencarroll.com",
+                    message: "API key expired. Renew at https://fda-csa-intel.jasencarroll.com",
                 };
             }
             // Optional blocklist check
@@ -262,30 +262,95 @@ export async function citationAnalysis(params) {
         csa_percentage: total > 0 ? Math.round((csaCount / total) * 100 * 10) / 10 : 0,
     };
 }
+export async function searchConsentDecrees(params) {
+    const p = getPool();
+    if (!p)
+        return null;
+    const conditions = [];
+    const values = [];
+    let idx = 1;
+    if (params.company_name) {
+        conditions.push(`LOWER(company_name) LIKE LOWER($${idx++})`);
+        values.push(`%${params.company_name}%`);
+    }
+    if (params.date_from) {
+        conditions.push(`issue_date >= $${idx++}`);
+        values.push(Math.floor(new Date(params.date_from).getTime() / 1000));
+    }
+    if (params.date_to) {
+        conditions.push(`issue_date <= $${idx++}`);
+        values.push(Math.floor(new Date(params.date_to).getTime() / 1000));
+    }
+    if (params.csa_relevant !== undefined) {
+        conditions.push(`csa_relevant = $${idx++}`);
+        values.push(params.csa_relevant);
+    }
+    const where = conditions.length > 0 ? `WHERE ${conditions.join(" AND ")}` : "";
+    const limit = Math.min(params.limit ?? 25, 100);
+    const countResult = await p.query(`SELECT COUNT(*) AS cnt FROM consent_decree ${where}`, values);
+    const rows = await p.query(`SELECT id, company_name,
+       CASE WHEN issue_date IS NOT NULL
+         THEN to_char(to_timestamp(issue_date), 'YYYY-MM-DD')
+         ELSE NULL
+       END AS issue_date,
+       court, docket_number, terms_summary,
+       csa_relevant, fei_number, source_url
+     FROM consent_decree
+     ${where}
+     ORDER BY issue_date DESC NULLS LAST
+     LIMIT $${idx}`, [...values, limit]);
+    return {
+        total: parseInt(countResult.rows[0]?.cnt ?? "0"),
+        decrees: rows.rows.map((r) => ({
+            id: r.id,
+            company_name: r.company_name,
+            issue_date: r.issue_date ?? null,
+            court: r.court ?? null,
+            docket_number: r.docket_number ?? null,
+            terms_summary: r.terms_summary ?? null,
+            csa_relevant: r.csa_relevant ?? false,
+            fei_number: r.fei_number ?? null,
+            source_url: r.source_url,
+        })),
+    };
+}
 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}%`]);
+    const [wlResult, wlCount, inspResult, inspCount, decreeResult, decreeCount] = await Promise.all([
+        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}%`]),
+        p.query(`SELECT COUNT(*) AS cnt FROM warning_letter WHERE LOWER(company_name) LIKE LOWER($1)`, [`%${companyName}%`]),
+        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}%`]),
+        p.query(`SELECT COUNT(*) AS cnt FROM observation_483 WHERE LOWER(company_name) LIKE LOWER($1)`, [`%${companyName}%`]),
+        p.query(`SELECT
+           CASE WHEN issue_date IS NOT NULL
+             THEN to_char(to_timestamp(issue_date), 'YYYY-MM-DD')
+             ELSE NULL
+           END AS issue_date,
+           court, terms_summary, csa_relevant, source_url
+         FROM consent_decree
+         WHERE LOWER(company_name) LIKE LOWER($1)
+         ORDER BY issue_date DESC NULLS LAST
+         LIMIT 5`, [`%${companyName}%`]),
+        p.query(`SELECT COUNT(*) AS cnt FROM consent_decree WHERE LOWER(company_name) LIKE LOWER($1)`, [`%${companyName}%`]),
+    ]);
     return {
         warning_letters: wlResult.rows.map((r) => ({
             issue_date: r.issue_date ?? "",
@@ -300,8 +365,16 @@ export async function companyEnrichedProfile(companyName) {
             product_area: r.product_area ?? "",
             csa_relevant: r.csa_relevant ?? false,
         })),
+        consent_decrees: decreeResult.rows.map((r) => ({
+            issue_date: r.issue_date ?? null,
+            court: r.court ?? null,
+            terms_summary: r.terms_summary ?? null,
+            csa_relevant: r.csa_relevant ?? false,
+            source_url: r.source_url,
+        })),
         total_warning_letters: parseInt(wlCount.rows[0]?.cnt ?? "0"),
         total_inspections: parseInt(inspCount.rows[0]?.cnt ?? "0"),
+        total_consent_decrees: parseInt(decreeCount.rows[0]?.cnt ?? "0"),
     };
 }
 export async function supplierQualification(companyName) {

package/dist/db.js.map

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

@@ -1 +1 @@
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+{"version":3,"file":"fda-client.d.ts","sourceRoot":"","sources":["../src/fda-client.ts"],"names":[],"mappings":"AAAA;;;;;;GAMG;AAcH,MAAM,WAAW,iBAAiB;IAChC,aAAa,EAAE,MAAM,CAAC;IACtB,MAAM,EAAE,MAAM,CAAC;IACf,cAAc,EAAE,MAAM,CAAC;IACvB,YAAY,EAAE,MAAM,CAAC;IACrB,cAAc,EAAE,MAAM,CAAC;IACvB,IAAI,EAAE,MAAM,CAAC;IACb,KAAK,EAAE,MAAM,CAAC;IACd,OAAO,EAAE,MAAM,CAAC;IAChB,iBAAiB,EAAE,MAAM,CAAC;IAC1B,mBAAmB,EAAE,MAAM,CAAC;IAC5B,gBAAgB,EAAE,MAAM,CAAC;IACzB,oBAAoB,EAAE,MAAM,CAAC;IAC7B,kBAAkB,EAAE,MAAM,CAAC;IAC3B,sBAAsB,EAAE,MAAM,CAAC;IAC/B,WAAW,EAAE,MAAM,CAAC;IACpB,0BAA0B,EAAE,MAAM,CAAC;IACnC,gBAAgB,EAAE,MAAM,CAAC;IACzB,QAAQ,EAAE,MAAM,CAAC;CAClB;AAED,MAAM,WAAW,iBAAiB;IAChC,aAAa,EAAE,MAAM,CAAC;IACtB,UAAU,EAAE,MAAM,CAAC;IACnB,aAAa,EAAE,MAAM,CAAC;IACtB,aAAa,EAAE,MAAM,CAAC;IACtB,WAAW,EAAE,MAAM,CAAC;IACpB,YAAY,EAAE,MAAM,CAAC;IACrB,UAAU,EAAE,MAAM,CAAC;IACnB,YAAY,EAAE,MAAM,CAAC;IACrB,iBAAiB,EAAE,MAAM,CAAC;IAC1B,eAAe,EAAE,MAAM,EAAE,CAAC;IAC1B,YAAY,EAAE,MAAM,CAAC;CACtB;AAID,wBAAsB,iBAAiB,CAAC,MAAM,EAAE;IAC9C,MAAM,CAAC,EAAE,MAAM,CAAC;IAChB,YAAY,CAAC,EAAE,MAAM,GAAG,QAAQ,GAAG,MAAM,CAAC;IAC1C,cAAc,CAAC,EAAE,SAAS,GAAG,UAAU,GAAG,WAAW,CAAC;IACtD,KAAK,CAAC,EAAE,MAAM,CAAC;IACf,cAAc,CAAC,EAAE,MAAM,CAAC;IACxB,SAAS,CAAC,EAAE,MAAM,CAAC;IACnB,OAAO,CAAC,EAAE,MAAM,CAAC;IACjB,KAAK,CAAC,EAAE,MAAM,CAAC;IACf,IAAI,CAAC,EAAE,MAAM,CAAC;CACf,GAAG,OAAO,CAAC;IAAE,KAAK,EAAE,MAAM,CAAC;IAAC,OAAO,EAAE,iBAAiB,EAAE,CAAA;CAAE,CAAC,CAmE3D;AAID,wBAAsB,kBAAkB,CAAC,MAAM,EAAE;IAC/C,MAAM,CAAC,EAAE,MAAM,CAAC;IAChB,YAAY,CAAC,EAAE,MAAM,CAAC;IACtB,UAAU,CAAC,EAAE,MAAM,CAAC;IACpB,UAAU,CAAC,EAAE,QAAQ,GAAG,aAAa,GAAG,OAAO,GAAG,OAAO,CAAC;IAC1D,YAAY,CAAC,EAAE,MAAM,CAAC;IACtB,SAAS,CAAC,EAAE,MAAM,CAAC;IACnB,OAAO,CAAC,EAAE,MAAM,CAAC;IACjB,KAAK,CAAC,EAAE,MAAM,CAAC;IACf,IAAI,CAAC,EAAE,MAAM,CAAC;CACf,GAAG,OAAO,CAAC;IAAE,KAAK,EAAE,MAAM,CAAC;IAAC,MAAM,EAAE,iBAAiB,EAAE,CAAA;CAAE,CAAC,CA0E1D"}

package/dist/fda-client.js

@@ -6,6 +6,13 @@
  * 2. Device Adverse Events (MAUDE database)
  */
 const OPENFDA_BASE = "https://api.fda.gov";
+const OPENFDA_API_KEY = process.env.OPENFDA_API_KEY;
+function withApiKey(url) {
+    if (OPENFDA_API_KEY) {
+        url.searchParams.set("api_key", OPENFDA_API_KEY);
+    }
+    return url;
+}
 // ─── openFDA Enforcement (Recalls) ───────────────────────────────────────────
 export async function searchEnforcement(params) {
     const product = params.product_type ?? "drug";
@@ -35,7 +42,7 @@ export async function searchEnforcement(params) {
     }
     url.searchParams.set("limit", String(limit));
     url.searchParams.set("skip", String(skip));
-    const resp = await fetch(url.toString(), {
+    const resp = await fetch(withApiKey(url).toString(), {
         headers: { "User-Agent": "fda-mcp-server/1.0" },
     });
     if (!resp.ok) {
@@ -100,7 +107,7 @@ export async function searchDeviceEvents(params) {
     }
     url.searchParams.set("limit", String(limit));
     url.searchParams.set("skip", String(skip));
-    const resp = await fetch(url.toString(), {
+    const resp = await fetch(withApiKey(url).toString(), {
         headers: { "User-Agent": "fda-mcp-server/1.0" },
     });
     if (!resp.ok) {

package/dist/fda-client.js.map

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package/dist/index.js

@@ -14,11 +14,12 @@ import { StdioServerTransport } from "@modelcontextprotocol/sdk/server/stdio.js"
 import { WebStandardStreamableHTTPServerTransport } from "@modelcontextprotocol/sdk/server/webStandardStreamableHttp.js";
 import { z } from "zod";
 import { searchEnforcement, searchDeviceEvents } from "./fda-client.js";
-import { isEnrichedAvailable, validateApiKey, testConnection, csaRiskAssessment, citationAnalysis, supplierQualification, companyEnrichedProfile, } from "./db.js";
+import { isEnrichedAvailable, validateApiKey, testConnection, csaRiskAssessment, citationAnalysis, supplierQualification, companyEnrichedProfile, searchConsentDecrees, } from "./db.js";
+import { isPlatformAvailable, callPlatformEngine } from "./platform-client.js";
 function createServer() {
     const server = new McpServer({
         name: "fda-mcp-server",
-        version: "1.0.0",
+        version: "0.0.16",
     });
     registerTools(server);
     return server;
@@ -33,7 +34,7 @@ function enrichedGate(apiKey) {
             content: [
                 {
                     type: "text",
-                    text: "This tool requires the enriched fda-csa-data dataset. Subscribe at https://fda-mcp.jasencarroll.com for access.",
+                    text: "This tool requires the enriched fda-csa-data dataset. Subscribe at https://fda-csa-intel.jasencarroll.com for access.",
                 },
             ],
         };
@@ -62,6 +63,35 @@ async function enrichedConnectionGate(apiKey) {
     }
     return { ok: true };
 }
+function enterpriseGate(apiKey) {
+    if (!isPlatformAvailable()) {
+        return {
+            ok: false,
+            content: [
+                {
+                    type: "text",
+                    text: "Engine tools require an Enterprise subscription and a running platform API.\n\nUpgrade at https://fda-csa-intel.jasencarroll.com",
+                },
+            ],
+        };
+    }
+    const auth = validateApiKey(apiKey);
+    if (!auth.valid) {
+        return { ok: false, content: [{ type: "text", text: auth.message }] };
+    }
+    if (auth.tier && auth.tier !== "enterprise") {
+        return {
+            ok: false,
+            content: [
+                {
+                    type: "text",
+                    text: `Engine tools require an Enterprise plan. Your current plan is: ${auth.tier}.\n\nUpgrade at https://fda-csa-intel.jasencarroll.com`,
+                },
+            ],
+        };
+    }
+    return { ok: true };
+}
 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.", {
@@ -210,6 +240,7 @@ function registerTools(server) {
             if (enriched) {
                 lines.push(`- **Warning Letters:** ${enriched.total_warning_letters}`);
                 lines.push(`- **483 Inspections:** ${enriched.total_inspections}`);
+                lines.push(`- **Consent Decrees:** ${enriched.total_consent_decrees}`);
             }
             lines.push(`- **Recalls:** ${recalls.total}`);
             lines.push(`- **Adverse Events:** ${events.total}`);
@@ -235,6 +266,17 @@ function registerTools(server) {
                 }
                 lines.push(``);
             }
+            // Consent decrees (enriched)
+            if (enriched && enriched.consent_decrees.length > 0) {
+                lines.push(`### Consent Decrees (${enriched.total_consent_decrees} total)`);
+                lines.push(`| Date | Court | CSA |`);
+                lines.push(`|------|-------|-----|`);
+                for (const d of enriched.consent_decrees) {
+                    const court = d.court ? d.court.substring(0, 50) : "Unknown";
+                    lines.push(`| ${d.issue_date ?? "Unknown"} | ${court} | ${d.csa_relevant ? "YES" : "no"} |`);
+                }
+                lines.push(``);
+            }
             // Recalls (live)
             if (recalls.records.length > 0) {
                 lines.push(`### Recalls (${recalls.total} total)`);
@@ -488,21 +530,237 @@ function registerTools(server) {
             };
         }
     });
+    // ─── Tool: search_consent_decrees (Pro) ──────────────────────────────────────
+    server.tool("search_consent_decrees", "Search FDA consent decrees and permanent injunctions from court records published as FDA press announcements. Filter by company, date range, or CSA relevance. Requires Pro subscription.", {
+        company_name: z.string().optional().describe("Filter by company name"),
+        date_from: z.string().optional().describe("Start date (YYYY-MM-DD)"),
+        date_to: z.string().optional().describe("End date (YYYY-MM-DD)"),
+        csa_relevant: z
+            .boolean()
+            .optional()
+            .describe("Filter to CSA-relevant decrees only"),
+        limit: z.number().min(1).max(100).optional().describe("Max results (default 25)"),
+    }, async (params, extra) => {
+        const gate = await enrichedConnectionGate(extra.authInfo?.token);
+        if (!gate.ok)
+            return { content: gate.content };
+        try {
+            const result = await searchConsentDecrees(params);
+            if (!result) {
+                return { content: [{ type: "text", text: "No consent decree data available." }] };
+            }
+            if (result.decrees.length === 0) {
+                return { content: [{ type: "text", text: "No consent decrees found." }] };
+            }
+            const lines = [
+                `## FDA Consent Decrees`,
+                `**${result.total} total** | Showing ${result.decrees.length}`,
+                ``,
+            ];
+            for (const d of result.decrees) {
+                lines.push(`### ${d.company_name}`);
+                lines.push(`- **Date:** ${d.issue_date ?? "Unknown"}`);
+                if (d.court)
+                    lines.push(`- **Court:** ${d.court}`);
+                if (d.docket_number)
+                    lines.push(`- **Docket:** ${d.docket_number}`);
+                lines.push(`- **CSA Relevant:** ${d.csa_relevant ? "YES" : "no"}`);
+                if (d.fei_number)
+                    lines.push(`- **FEI:** ${d.fei_number}`);
+                if (d.terms_summary) {
+                    const summary = d.terms_summary.length > 150
+                        ? d.terms_summary.substring(0, 150) + "..."
+                        : d.terms_summary;
+                    lines.push(`- **Terms:** ${summary}`);
+                }
+                lines.push(`- **Source:** ${d.source_url}`);
+                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,
+            };
+        }
+    });
+    // ─── Engine Tools (Enterprise) ────────────────────────────────────────────────
+    server.tool("csa_recommendation", "Run the CSA recommender engine on a specific company's enforcement data. Returns a 10-node risk score, validation gap analysis, recommended actions, and prioritized remediation roadmap. Requires Enterprise subscription.", {
+        company_name: z.string().describe("Company name to assess"),
+        fei_number: z.string().optional().describe("FEI number for precise matching"),
+        product_type: z
+            .enum(["device", "drug", "combination"])
+            .optional()
+            .describe("Product type"),
+    }, async (params, extra) => {
+        const gate = enterpriseGate(extra.authInfo?.token);
+        if (!gate.ok)
+            return { content: gate.content };
+        try {
+            const result = await callPlatformEngine("csa", params);
+            return {
+                content: [{ type: "text", text: JSON.stringify(result, null, 2) }],
+            };
+        }
+        catch (error) {
+            return {
+                content: [
+                    {
+                        type: "text",
+                        text: `Error: ${error instanceof Error ? error.message : String(error)}`,
+                    },
+                ],
+                isError: true,
+            };
+        }
+    });
+    server.tool("sdlc_classification", "Classify medical device software under IEC 62304 and determine software safety class, required development activities, documentation checklist, and applicable standards. Requires Enterprise subscription.", {
+        intended_use: z.string().describe("Intended use of the software / device"),
+        harm_severity: z
+            .enum(["negligible", "minor", "serious", "critical", "catastrophic"])
+            .describe("Worst-case harm severity if software fails"),
+        harm_probability: z
+            .enum(["improbable", "remote", "occasional", "probable", "frequent"])
+            .describe("Probability of harm occurring without mitigation"),
+        software_role: z
+            .enum(["standalone", "embedded", "infrastructure"])
+            .optional()
+            .describe("Role of the software in the device system"),
+        soup_items: z
+            .array(z.string())
+            .optional()
+            .describe("List of SOUP (Software of Unknown Provenance) component names"),
+        markets: z
+            .array(z.string())
+            .optional()
+            .describe("Target markets (e.g., US, EU, Japan)"),
+    }, async (params, extra) => {
+        const gate = enterpriseGate(extra.authInfo?.token);
+        if (!gate.ok)
+            return { content: gate.content };
+        try {
+            const result = await callPlatformEngine("sdlc", params);
+            return {
+                content: [{ type: "text", text: JSON.stringify(result, null, 2) }],
+            };
+        }
+        catch (error) {
+            return {
+                content: [
+                    {
+                        type: "text",
+                        text: `Error: ${error instanceof Error ? error.message : String(error)}`,
+                    },
+                ],
+                isError: true,
+            };
+        }
+    });
+    server.tool("qmsr_gap_analysis", "Analyze a medical device manufacturer's Quality Management System for gaps against 21 CFR Part 820 (QMSR). Returns prioritized gap list with effort estimates, remediation roadmap, and estimated timeline. Requires Enterprise subscription.", {
+        company_size: z
+            .enum(["startup", "small", "medium", "large"])
+            .describe("Company size category"),
+        product_type: z
+            .enum(["device", "drug", "combination"])
+            .optional()
+            .describe("Product type"),
+        implemented_clauses: z
+            .array(z.string())
+            .optional()
+            .describe("List of 820 clauses already implemented (e.g., ['820.20', '820.30'])"),
+        missing_clauses: z
+            .array(z.string())
+            .optional()
+            .describe("List of 820 clauses known to be missing or deficient"),
+    }, async (params, extra) => {
+        const gate = enterpriseGate(extra.authInfo?.token);
+        if (!gate.ok)
+            return { content: gate.content };
+        try {
+            const result = await callPlatformEngine("qmsr", params);
+            return {
+                content: [{ type: "text", text: JSON.stringify(result, null, 2) }],
+            };
+        }
+        catch (error) {
+            return {
+                content: [
+                    {
+                        type: "text",
+                        text: `Error: ${error instanceof Error ? error.message : String(error)}`,
+                    },
+                ],
+                isError: true,
+            };
+        }
+    });
+    server.tool("capa_assessment", "Assess a CAPA (Corrective and Preventive Action) for effectiveness, closure readiness, and risk. Returns risk score, valid state transitions, monitoring strategy, and aging alert if overdue. Requires Enterprise subscription.", {
+        capa_type: z
+            .enum(["corrective", "preventive", "both"])
+            .describe("CAPA type"),
+        current_state: z
+            .enum(["initiated", "root_cause_analysis", "action_plan", "implementation", "verification", "closed"])
+            .describe("Current CAPA state"),
+        root_cause_category: z
+            .enum(["human_error", "process", "equipment", "software", "supplier", "design", "environment", "unknown"])
+            .describe("Root cause category"),
+        scope: z
+            .enum(["local", "site", "global"])
+            .describe("CAPA scope / extent of impact"),
+        customer_impact: z.boolean().describe("Whether the issue reached customers"),
+        regulatory_reportable: z.boolean().describe("Whether the issue is regulatory reportable"),
+        days_open: z.number().int().min(0).describe("Number of days the CAPA has been open"),
+    }, async (params, extra) => {
+        const gate = enterpriseGate(extra.authInfo?.token);
+        if (!gate.ok)
+            return { content: gate.content };
+        try {
+            const result = await callPlatformEngine("capa", params);
+            return {
+                content: [{ type: "text", text: JSON.stringify(result, null, 2) }],
+            };
+        }
+        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();
+    const platform = isPlatformAvailable();
     console.error(`FDA MCP Server running on ${mode}`);
-    console.error("  Tools: search_recalls, search_device_events, company_enforcement_profile");
+    console.error("  Free tools: search_recalls, search_device_events, company_enforcement_profile");
     if (enriched) {
         const connected = await testConnection();
-        console.error(`  Enriched tools: ${connected ? "ACTIVE" : "DATABASE_URL set but connection failed"}`);
+        console.error(`  Pro tools (DB): ${connected ? "ACTIVE" : "DATABASE_URL set but connection failed"}`);
         if (connected) {
-            console.error("  + csa_risk_assessment, citation_analysis, supplier_qualification_report");
+            console.error("  + csa_risk_assessment, citation_analysis, supplier_qualification_report, search_consent_decrees");
         }
     }
     else {
-        console.error("  Enriched tools: INACTIVE (set DATABASE_URL to enable)");
+        console.error("  Pro tools: INACTIVE (set DATABASE_URL to enable)");
+    }
+    if (platform) {
+        console.error("  Enterprise tools (Platform API): ACTIVE");
+        console.error("  + csa_recommendation, sdlc_classification, qmsr_gap_analysis, capa_assessment");
+    }
+    else {
+        console.error("  Enterprise tools: INACTIVE (set PLATFORM_API_URL to enable)");
     }
 }
 async function main() {
@@ -575,6 +833,14 @@ async function main() {
                             });
                         }
                     }
+                    if (rateLimits.size > 1000) {
+                        const now = Date.now();
+                        for (const [k, v] of rateLimits) {
+                            if (now - v.windowStart > RATE_WINDOW_MS) {
+                                rateLimits.delete(k);
+                            }
+                        }
+                    }
                     const sessionId = req.headers.get("mcp-session-id");
                     // Existing session — route to its transport
                     if (sessionId && transports.has(sessionId)) {

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package/dist/platform-client.d.ts

@@ -0,0 +1,14 @@
+/**
+ * Platform API client — proxies requests to the fda-platform backend.
+ *
+ * Engine tools (Enterprise tier) call POST /api/engines/* on the platform API.
+ * The platform URL defaults to http://localhost:8000 for local dev.
+ * In Docker / Railway: set PLATFORM_API_URL=http://app:8000
+ */
+export declare function isPlatformAvailable(): boolean;
+export declare function translateSdlcParams(mcpParams: Record<string, unknown>): Record<string, unknown>;
+export declare function translateQmsrParams(mcpParams: Record<string, unknown>): Record<string, unknown>;
+export declare function translateCapaParams(mcpParams: Record<string, unknown>): Record<string, unknown>;
+export declare function translateCsaParams(mcpParams: Record<string, unknown>): Record<string, unknown>;
+export declare function callPlatformEngine(endpoint: string, params: Record<string, unknown>): Promise<Record<string, unknown>>;
+//# sourceMappingURL=platform-client.d.ts.map

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

@@ -0,0 +1 @@
+{"version":3,"file":"platform-client.d.ts","sourceRoot":"","sources":["../src/platform-client.ts"],"names":[],"mappings":"AAAA;;;;;;GAMG;AAMH,wBAAgB,mBAAmB,IAAI,OAAO,CAE7C;AAsBD,wBAAgB,mBAAmB,CACjC,SAAS,EAAE,MAAM,CAAC,MAAM,EAAE,OAAO,CAAC,GACjC,MAAM,CAAC,MAAM,EAAE,OAAO,CAAC,CAiCzB;AA6BD,wBAAgB,mBAAmB,CACjC,SAAS,EAAE,MAAM,CAAC,MAAM,EAAE,OAAO,CAAC,GACjC,MAAM,CAAC,MAAM,EAAE,OAAO,CAAC,CA8BzB;AAyCD,wBAAgB,mBAAmB,CACjC,SAAS,EAAE,MAAM,CAAC,MAAM,EAAE,OAAO,CAAC,GACjC,MAAM,CAAC,MAAM,EAAE,OAAO,CAAC,CA6BzB;AAMD,wBAAgB,kBAAkB,CAChC,SAAS,EAAE,MAAM,CAAC,MAAM,EAAE,OAAO,CAAC,GACjC,MAAM,CAAC,MAAM,EAAE,OAAO,CAAC,CAsBzB;AAgBD,wBAAsB,kBAAkB,CACtC,QAAQ,EAAE,MAAM,EAChB,MAAM,EAAE,MAAM,CAAC,MAAM,EAAE,OAAO,CAAC,GAC9B,OAAO,CAAC,MAAM,CAAC,MAAM,EAAE,OAAO,CAAC,CAAC,CAwBlC"}

package/dist/platform-client.js

@@ -0,0 +1,223 @@
+/**
+ * Platform API client — proxies requests to the fda-platform backend.
+ *
+ * Engine tools (Enterprise tier) call POST /api/engines/* on the platform API.
+ * The platform URL defaults to http://localhost:8000 for local dev.
+ * In Docker / Railway: set PLATFORM_API_URL=http://app:8000
+ */
+const PLATFORM_API_URL = process.env.PLATFORM_API_URL ?? "http://localhost:8000";
+const PLATFORM_INTERNAL_SECRET = process.env.PLATFORM_INTERNAL_SECRET;
+export function isPlatformAvailable() {
+    return !!process.env.PLATFORM_API_URL;
+}
+// ── SDLC param translation ──────────────────────────────────
+const HARM_SEVERITY_MAP = {
+    catastrophic: "Can contribute, serious injury or death",
+    critical: "Can contribute, serious injury or death",
+    serious: "Can contribute, non-serious",
+    minor: "Can contribute, non-serious",
+    negligible: "cannot_contribute",
+};
+const SOFTWARE_ROLE_MAP = {
+    standalone: "SaMD",
+    embedded: "SiMD",
+    infrastructure: "QMS_Software",
+};
+const SDLC_KNOWN_KEYS = [
+    "intended_use", "soup_items", "harm_severity", "software_role", "markets",
+];
+export function translateSdlcParams(mcpParams) {
+    const intendedUse = mcpParams.intended_use ?? "";
+    const soupItems = mcpParams.soup_items ?? [];
+    const harmSeverity = mcpParams.harm_severity ?? "negligible";
+    const softwareRole = mcpParams.software_role ?? "standalone";
+    const markets = mcpParams.markets ?? ["US"];
+    return {
+        name: intendedUse.slice(0, 50) || "Software Assessment",
+        role: SOFTWARE_ROLE_MAP[softwareRole] ?? "SaMD",
+        description: intendedUse,
+        intended_use: intendedUse,
+        harm_contribution: HARM_SEVERITY_MAP[harmSeverity] ?? "cannot_contribute",
+        target_markets: markets,
+        uses_ai_ml: false,
+        is_cloud_deployed: false,
+        soup_components: soupItems.map((name) => ({
+            name,
+            version: "unknown",
+            purpose: "SOUP",
+            manufacturer: "unknown",
+            is_open_source: false,
+            known_anomalies: false,
+            last_updated: "",
+            has_security_advisories: false,
+            clinical_function: false,
+        })),
+        software_items: [],
+        // Pass through any additional params the user explicitly provided
+        ...Object.fromEntries(Object.entries(mcpParams).filter(([k]) => !SDLC_KNOWN_KEYS.includes(k))),
+    };
+}
+// ── QMSR param translation ──────────────────────────────────
+const EMPLOYEE_COUNT_MAP = {
+    startup: 10,
+    small: 50,
+    medium: 200,
+    large: 1000,
+};
+const PRODUCT_TYPE_TO_COMPANY_TYPE = {
+    device: "Device Only",
+    drug: "Device Only",
+    combination: "Combination Product",
+};
+const COMMON_820_CLAUSES = [
+    "820.5", "820.20", "820.22", "820.25", "820.30(a)", "820.30(c)",
+    "820.30(d)", "820.30(e)", "820.30(f)", "820.30(g)", "820.30(h)",
+    "820.30(i)", "820.30(j)", "820.40", "820.50", "820.60", "820.65",
+    "820.70", "820.72", "820.75", "820.90", "820.180", "820.198",
+    "820.20(c)",
+];
+const QMSR_KNOWN_KEYS = [
+    "company_size", "product_type", "implemented_clauses", "missing_clauses",
+];
+export function translateQmsrParams(mcpParams) {
+    const companySize = mcpParams.company_size ?? "small";
+    const productType = mcpParams.product_type;
+    const implemented = mcpParams.implemented_clauses ?? [];
+    const missing = mcpParams.missing_clauses ?? [];
+    const compliance = {};
+    for (const clause of implemented)
+        compliance[clause] = "Implemented";
+    for (const clause of missing)
+        compliance[clause] = "Not Implemented";
+    for (const clause of COMMON_820_CLAUSES) {
+        if (!(clause in compliance))
+            compliance[clause] = "Partial";
+    }
+    return {
+        company_name: "Assessment",
+        company_type: productType
+            ? (PRODUCT_TYPE_TO_COMPANY_TYPE[productType] ?? "Device Only")
+            : "Device Only",
+        has_iso13485: false,
+        iso13485_certified: false,
+        has_eu_mdr_compliance: false,
+        markets: ["US"],
+        employee_count: EMPLOYEE_COUNT_MAP[companySize] ?? 50,
+        product_count: 1,
+        current_820_compliance: compliance,
+        // Pass through any additional params the user explicitly provided
+        ...Object.fromEntries(Object.entries(mcpParams).filter(([k]) => !QMSR_KNOWN_KEYS.includes(k))),
+    };
+}
+// ── CAPA param translation ───────────────────────────────────
+const CAPA_STATE_MAP = {
+    initiated: "Initiated",
+    root_cause_analysis: "Investigation",
+    action_plan: "Action Plan Defined",
+    implementation: "Implementation",
+    verification: "Effectiveness Check",
+    closed: "Closed — Effective",
+};
+const CAPA_TYPE_MAP = {
+    corrective: "Corrective",
+    preventive: "Preventive",
+    both: "Both",
+};
+const ROOT_CAUSE_MAP = {
+    human_error: "Human Error",
+    process: "Process Capability",
+    equipment: "Equipment/System Failure",
+    software: "Software Defect",
+    supplier: "Supplier Quality",
+    design: "Design Deficiency",
+    environment: "Environmental",
+    unknown: "Undetermined",
+};
+const SCOPE_MAP = {
+    local: "Local",
+    site: "Multi-site",
+    global: "Systemic",
+};
+const CAPA_KNOWN_KEYS = [
+    "days_open", "customer_impact", "capa_type", "current_state",
+    "root_cause_category", "scope", "regulatory_reportable",
+];
+export function translateCapaParams(mcpParams) {
+    const daysOpen = mcpParams.days_open ?? 0;
+    const customerImpact = mcpParams.customer_impact ?? false;
+    return {
+        capa_id: `MCP-${Date.now()}`,
+        capa_type: CAPA_TYPE_MAP[mcpParams.capa_type ?? "corrective"] ?? "Corrective",
+        current_state: CAPA_STATE_MAP[mcpParams.current_state ?? "initiated"] ?? "Initiated",
+        title: "CAPA Assessment via MCP",
+        description: `${mcpParams.capa_type ?? "corrective"} action — ${mcpParams.root_cause_category ?? "unknown"} root cause`,
+        source: "MCP Assessment",
+        root_cause_category: ROOT_CAUSE_MAP[mcpParams.root_cause_category ?? "unknown"] ?? "Undetermined",
+        rca_method: null,
+        scope: SCOPE_MAP[mcpParams.scope ?? "local"] ?? "Local",
+        product_impact: customerImpact ? "Major" : "None",
+        days_open: daysOpen,
+        days_in_current_state: daysOpen,
+        related_capas: [],
+        recurrence_count: 0,
+        actions_defined: 0,
+        actions_completed: 0,
+        effectiveness_checks_performed: 0,
+        last_effectiveness_result: null,
+        regulatory_reported: mcpParams.regulatory_reportable ?? false,
+        // Pass through any additional params the user explicitly provided
+        ...Object.fromEntries(Object.entries(mcpParams).filter(([k]) => !CAPA_KNOWN_KEYS.includes(k))),
+    };
+}
+// ── CSA param translation ────────────────────────────────────
+const CSA_KNOWN_KEYS = ["company_name"];
+export function translateCsaParams(mcpParams) {
+    const companyName = mcpParams.company_name ?? "System";
+    return {
+        name: companyName,
+        system_type: "GxP System",
+        deployment: "SaaS",
+        gamp_category: 4,
+        gxp_impact: "Direct",
+        geographic_scope: ["US"],
+        intended_use: `GxP-regulated system for ${companyName}`,
+        vendor_name: companyName,
+        vendor_years: 0,
+        vendor_soc2: false,
+        vendor_audit_clean: true,
+        has_ai_component: false,
+        has_e_signatures: false,
+        // Pass through any additional params the user explicitly provided
+        ...Object.fromEntries(Object.entries(mcpParams).filter(([k]) => !CSA_KNOWN_KEYS.includes(k))),
+    };
+}
+// ── Translator registry ──────────────────────────────────────
+const PARAM_TRANSLATORS = {
+    sdlc: translateSdlcParams,
+    qmsr: translateQmsrParams,
+    capa: translateCapaParams,
+    csa: translateCsaParams,
+};
+// ── API call ─────────────────────────────────────────────────
+export async function callPlatformEngine(endpoint, params) {
+    const url = `${PLATFORM_API_URL}/api/engines/${endpoint}`;
+    const translator = PARAM_TRANSLATORS[endpoint];
+    const body = translator ? translator(params) : params;
+    const headers = {
+        "Content-Type": "application/json",
+    };
+    if (PLATFORM_INTERNAL_SECRET) {
+        headers["X-Internal-Secret"] = PLATFORM_INTERNAL_SECRET;
+    }
+    const resp = await fetch(url, {
+        method: "POST",
+        headers,
+        body: JSON.stringify(body),
+    });
+    if (!resp.ok) {
+        const text = await resp.text().catch(() => resp.statusText);
+        throw new Error(`Platform API error ${resp.status}: ${text}`);
+    }
+    return resp.json();
+}
+//# sourceMappingURL=platform-client.js.map

package/dist/platform-client.js.map

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package/package.json

@@ -1,7 +1,7 @@
 {
   "name": "fda-mcp-server",
-  "version": "0.0.15",
-  "description": "MCP server for FDA Warning Letters, Form 483 Inspections, and Enforcement/Recall data. Query FDA public data from any MCP client.",
+  "version": "0.0.17",
+  "description": "11-tool MCP server for FDA enforcement intelligence. Free: recalls, device events, company profiles. Pro: CSA risk, citation analysis, supplier qualification, consent decrees. Enterprise: CSA recommendation, IEC 62304 SDLC, QMSR gap analysis, CAPA assessment.",
   "type": "module",
   "main": "dist/index.js",
   "bin": {
@@ -32,15 +32,20 @@
     "medical-device",
     "pharma",
     "openfda",
-    "model-context-protocol"
+    "model-context-protocol",
+    "consent-decree",
+    "csa",
+    "capa",
+    "iec-62304",
+    "qmsr"
   ],
   "author": "Jasen Carroll <jasen.c7@gmail.com>",
   "license": "MIT",
   "repository": {
     "type": "git",
-    "url": "https://github.com/jasencarroll/fda-mcp-server"
+    "url": "https://github.com/jasencarroll/fda-platform"
   },
-  "homepage": "https://github.com/jasencarroll/fda-mcp-server#readme",
+  "homepage": "https://github.com/jasencarroll/fda-platform#readme",
   "publishConfig": {
     "access": "public",
     "registry": "https://registry.npmjs.org/"