# FDA Import Alert & Supplier Ban Monitor (`achmadanam/fda-import-alert-monitor`) Actor Screen suppliers against FDA import alerts, border refusals, recalls and warning letters. FSVP-ready risk score + recommended action per supplier. Covers food, supplements, cosmetics, pharma, devices. - **URL**: https://apify.com/achmadanam/fda-import-alert-monitor.md - **Developed by:** [Achmad Khairul Anam](https://apify.com/achmadanam) (community) - **Categories:** AI, Automation, E-commerce - **Stats:** 2 total users, 1 monthly users, 0.0% runs succeeded, 0 bookmarks - **User rating**: No ratings yet ## Pricing Pay per usage This Actor is paid per platform usage. The Actor is free to use, and you only pay for the Apify platform usage, which gets cheaper the higher subscription plan you have. Learn more: https://docs.apify.com/platform/actors/running/actors-in-store#pay-per-usage ## What's an Apify Actor? Actors are a software tools running on the Apify platform, for all kinds of web data extraction and automation use cases. In Batch mode, an Actor accepts a well-defined JSON input, performs an action which can take anything from a few seconds to a few hours, and optionally produces a well-defined JSON output, datasets with results, or files in key-value store. In Standby mode, an Actor provides a web server which can be used as a website, API, or an MCP server. Actors are written with capital "A". ## How to integrate an Actor? If asked about integration, you help developers integrate Actors into their projects. You adapt to their stack and deliver integrations that are safe, well-documented, and production-ready. The best way to integrate Actors is as follows. In JavaScript/TypeScript projects, use official [JavaScript/TypeScript client](https://docs.apify.com/api/client/js.md): ```bash npm install apify-client ``` In Python projects, use official [Python client library](https://docs.apify.com/api/client/python.md): ```bash pip install apify-client ``` In shell scripts, use [Apify CLI](https://docs.apify.com/cli/docs.md): ````bash # MacOS / Linux curl -fsSL https://apify.com/install-cli.sh | bash # Windows irm https://apify.com/install-cli.ps1 | iex ```bash In AI frameworks, you might use the [Apify MCP server](https://docs.apify.com/platform/integrations/mcp.md). If your project is in a different language, use the [REST API](https://docs.apify.com/api/v2.md). For usage examples, see the [API](#api) section below. For more details, see Apify documentation as [Markdown index](https://docs.apify.com/llms.txt) and [Markdown full-text](https://docs.apify.com/llms-full.txt). # README ## FDA Import Alert & FSVP Supplier Screening — Refusals, Recalls, Risk Score Screen suppliers against FDA enforcement data and get an FSVP-ready risk report per supplier in under 30 seconds. Covers import alerts, border refusals, recalls, and warning letters — everything an importer needs to satisfy the Foreign Supplier Verification Program before a shipment arrives. --- ### Why this matters Under FSMA's Foreign Supplier Verification Program (FSVP), U.S. importers are legally required to verify that each foreign supplier produces food in a manner that meets U.S. safety standards — **before every shipment**. A supplier on FDA's import alert list (DWPE — Detention Without Physical Examination) means your cargo is detained at the border automatically, without FDA even opening it. The financial exposure is real: a single detained shipment typically costs **$100,000–$500,000** once you account for demurrage, re-exportation or destruction costs, product loss, and the expedited review fees to get off the alert. Importers are also required to keep records of their supplier verification activities for FDA inspection — a manual process that this actor automates and documents. This actor runs in seconds, covers the four primary FDA enforcement databases, and produces a structured risk report with a 0–100 score and a recommended action you can act on immediately. --- ### What gets checked | Source | What it means | Update frequency | |--------|--------------|-----------------| | **FDA Import Alerts (Red List)** | Firms subject to DWPE — cargo is detained at the border without physical examination. The most serious enforcement status. | Cached, refreshed every 6 hours | | **Import Refusals (OASIS)** | Actual border rejections by FDA inspectors — shipments that were examined and refused entry. Includes refusal charges (e.g. "Filth", "Unsafe Color Additive"). | Monthly | | **Recalls & Enforcement (openFDA)** | Class I, II, and III recalls reported to FDA. Class I = risk of serious adverse health consequences or death. | Weekly | | **Warning Letters** | FDA's formal notice to a firm that it is in significant violation of FDA regulations. Often a precursor to more severe action. | As issued | Each result also includes `match_confidence` — `exact` when an FEI number was provided, or `high`/`medium`/`low` for name-based fuzzy matching — so you know how reliable the lookup was. --- ### Risk score Every supplier gets a **0–100 risk score** built from the sources above, plus a plain-English `risk_explanation` array that lists exactly which findings drove the score. No AI is required to produce the number — it is fully deterministic. | Score | Level | Recommended action | |-------|-------|--------------------| | 0–15 | `clean` | `APPROVED` — No enforcement records found. Document and proceed. | | 16–35 | `low` | `MONITOR` — Minor or dated findings. Continue monitoring on schedule. | | 36–65 | `medium` | `REVIEW_REQUIRED` — Active refusals or recent warning letter. Request corrective action documentation from supplier before next shipment. | | 66–85 | `high` | `HOLD_SHIPMENT` — Active import alert or Class I recall. Obtain third-party audit; hold next shipment pending review. | | 86–100 | `critical` | `REJECT_SUPPLIER` — Multiple active alerts or compound violations. Sourcing from this supplier is not advisable under current FDA status. | --- ### Input example ```json { "suppliers": [ { "name": "MAOMING HONGYE AQUATIC PRODUCTS CO., LTD.", "fei_number": "3010761139", "country": "CN", "product_category": "seafood", "internal_id": "SUPPLIER-001" }, { "name": "Sunland Inc", "country": "US", "product_category": "food", "internal_id": "SUPPLIER-002" } ], "mode": "screen", "include_removed_alerts": false } ```` Providing `fei_number` (FDA Establishment Identifier) gives an exact match across all sources. If you only have a company name, the actor performs fuzzy name matching and reports the confidence level. *** ### Output example Truncated output for MAOMING HONGYE AQUATIC PRODUCTS (real public FDA data): ```json { "supplier_name": "MAOMING HONGYE AQUATIC PRODUCTS CO., LTD.", "fei_number": "3010761139", "internal_id": "SUPPLIER-001", "screened_at": "2026-06-24T10:30:00.000Z", "risk_score": 40, "risk_level": "medium", "recommended_action": "REVIEW_REQUIRED", "risk_explanation": [ { "factor": "import_refusals_recent", "detail": "19 import refusals in the last 12 months (+25 pts)" }, { "factor": "import_refusals_high_volume", "detail": "More than 3 refusals in 12 months — elevated pattern (+15 pts)" } ], "active_import_alerts_count": 0, "refusals_last_12mo": 19, "recalls_count": 0, "match_confidence": "exact", "change_detected": false, "data_sources_checked": [ "import_alerts", "import_refusals", "recalls", "warning_letters" ] } ``` The full output includes the complete `refusals[]`, `recalls[]`, and `warning_letters[]` arrays with all raw FDA fields. *** ### Batch screening Submit up to **50 suppliers** in a single run. All suppliers are screened in parallel (up to 5 concurrent) and results are pushed to the Apify dataset as they complete. Each result is independent — a timeout on one supplier does not affect others. *** ### Snapshot history and change detection Every run persists a status snapshot per supplier to a named Apify KeyValueStore (`fda-firm-latest`). On the next run, the actor diffs the current result against the prior snapshot and sets `change_detected: true` if the risk score, refusal count, alert count, or recall count changed. This enables **scheduled monitoring**: run weekly, and you only need to review suppliers where `change_detected` is `true`. Over time, the named Dataset `fda-firm-history` accumulates a time-series for each supplier — a record no fresh lookup can produce. *** ### Limitations - **Import refusals require a country code** (`country` field, ISO-2 format such as `"CN"` or `"IN"`). Without a country, the refusal check is skipped and noted in `data_sources_checked` as `import_refusals_skipped_no_country`. Providing `fei_number` as an alternative also enables the refusal lookup. - **Import alert index refreshes every 6 hours.** The first run of the day crawls ~154 FDA alert pages (~2–5 minutes). Subsequent runs within 6 hours use the cached index and complete in under 30 seconds. - **Warning letter search requires a browser session** (FDA's search is JavaScript-rendered). This adds a few seconds per supplier. If the FDA site is slow, the warning letter check times out gracefully and returns an empty array — the score still reflects the other three sources. - **Name matching is fuzzy, not exact.** When no FEI number is supplied, the actor normalizes and compares firm names against FDA records. Match confidence is always reported. Provide the FEI number when available for a guaranteed exact match. - **Data reflects what FDA has published.** There is typically a 30-day lag on import refusals (monthly update cycle) and up to 1 week on recalls. *** ### Pricing | Action | Cost | |--------|------| | Per supplier screened (`mode: "screen"`) | **$1.00** | | Per monitoring check (`mode: "monitor"`, scheduled) | **$0.10** | | Free tier | 3 suppliers/month | Charges are per-event via Apify's Pay-Per-Event billing and appear in your Apify usage dashboard. *** ### Environment variables | Variable | Required | Purpose | |----------|----------|---------| | `OPENFDA_API_KEY` | Recommended | Free key from [open.fda.gov/apis/](https://open.fda.gov/apis/). Raises daily recall lookup limit from 1,000 to 120,000 requests. | | `OPENROUTER_API_KEY` | No | Phase 2 — AI-generated risk summaries via DeepSeek V4 Flash (openrouter.ai). Active when set and risk score > 0. | | `RESEND_API_KEY` | No | Phase 3 — email alerts when `change_detected` is true on a scheduled monitoring run. | *** ### Disclaimer This actor screens publicly available FDA databases. Results reflect data that FDA has published and may not capture enforcement actions taken within the last 30 days. This is not legal advice. Consult a regulatory attorney for FSVP compliance strategy specific to your import program. # Actor input Schema ## `suppliers` (type: `array`): List of suppliers. Provide FEI number when known for exact, faster, more accurate matching. ## `mode` (type: `string`): screen = one-time check. monitor = scheduled run, alert only when a firm's status changes. ## `product_categories` (type: `array`): Optional. Narrows alert/refusal matching to these categories. ## `include_removed_alerts` (type: `boolean`): If true, includes past (resolved) import alerts as yellow flags. ## `min_risk_score_alert` (type: `integer`): Only send a notification when risk score >= this value. ## `notify_email` (type: `string`): Optional. Where to send change alerts. Requires RESEND\_API\_KEY. ## Actor input object example ```json { "suppliers": [ { "name": "EXAMPLE FOODS CO LTD", "country": "CN", "product_category": "seafood" } ], "mode": "screen", "product_categories": [ "all" ], "include_removed_alerts": false, "min_risk_score_alert": 30 } ``` # API You can run this Actor programmatically using our API. Below are code examples in JavaScript, Python, and CLI, as well as the OpenAPI specification and MCP server setup. ## JavaScript example ```javascript import { ApifyClient } from 'apify-client'; // Initialize the ApifyClient with your Apify API token // Replace the '' with your token const client = new ApifyClient({ token: '', }); // Prepare Actor input const input = { "suppliers": [ { "name": "EXAMPLE FOODS CO LTD", "country": "CN", "product_category": "seafood" } ] }; // Run the Actor and wait for it to finish const run = await client.actor("achmadanam/fda-import-alert-monitor").call(input); // Fetch and print Actor results from the run's dataset (if any) console.log('Results from dataset'); console.log(`💾 Check your data here: https://console.apify.com/storage/datasets/${run.defaultDatasetId}`); const { items } = await client.dataset(run.defaultDatasetId).listItems(); items.forEach((item) => { console.dir(item); }); // 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/js/docs ``` ## Python example ```python from apify_client import ApifyClient # Initialize the ApifyClient with your Apify API token # Replace '' with your token. client = ApifyClient("") # Prepare the Actor input run_input = { "suppliers": [{ "name": "EXAMPLE FOODS CO LTD", "country": "CN", "product_category": "seafood", }] } # Run the Actor and wait for it to finish run = client.actor("achmadanam/fda-import-alert-monitor").call(run_input=run_input) # Fetch and print Actor results from the run's dataset (if there are any) print("💾 Check your data here: https://console.apify.com/storage/datasets/" + run["defaultDatasetId"]) for item in client.dataset(run["defaultDatasetId"]).iterate_items(): print(item) # 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start ``` ## CLI example ```bash echo '{ "suppliers": [ { "name": "EXAMPLE FOODS CO LTD", "country": "CN", "product_category": "seafood" } ] }' | apify call achmadanam/fda-import-alert-monitor --silent --output-dataset ``` ## MCP server setup ```json { "mcpServers": { "apify": { "command": "npx", "args": [ "mcp-remote", "https://mcp.apify.com/?tools=achmadanam/fda-import-alert-monitor", "--header", "Authorization: Bearer " ] } } } ``` ## OpenAPI specification ```json { "openapi": "3.0.1", "info": { "title": "FDA Import Alert & Supplier Ban Monitor", "description": "Screen suppliers against FDA import alerts, border refusals, recalls and warning letters. FSVP-ready risk score + recommended action per supplier. Covers food, supplements, cosmetics, pharma, devices.", "version": "1.0", "x-build-id": "ZuttTUvjoZCYAfuhG" }, "servers": [ { "url": "https://api.apify.com/v2" } ], "paths": { "/acts/achmadanam~fda-import-alert-monitor/run-sync-get-dataset-items": { "post": { "operationId": "run-sync-get-dataset-items-achmadanam-fda-import-alert-monitor", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for its completion, and returns Actor's dataset items in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } }, "/acts/achmadanam~fda-import-alert-monitor/runs": { "post": { "operationId": "runs-sync-achmadanam-fda-import-alert-monitor", "x-openai-isConsequential": false, "summary": "Executes an Actor and returns information about the initiated run in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/runsResponseSchema" } } } } } } }, "/acts/achmadanam~fda-import-alert-monitor/run-sync": { "post": { "operationId": "run-sync-achmadanam-fda-import-alert-monitor", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for completion, and returns the OUTPUT from Key-value store in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } } }, "components": { "schemas": { "inputSchema": { "type": "object", "required": [ "suppliers" ], "properties": { "suppliers": { "title": "Suppliers to screen", "type": "array", "description": "List of suppliers. Provide FEI number when known for exact, faster, more accurate matching.", "items": { "type": "object", "properties": { "name": { "type": "string", "title": "Company name", "description": "Legal name of the supplier firm. Used for fuzzy matching against FDA databases when no FEI is provided." }, "fei_number": { "type": "string", "title": "FDA Establishment Identifier (FEI)", "description": "10-digit FDA Establishment Identifier. Enables exact matching across all FDA sources. Preferred over name-only lookup." }, "country": { "type": "string", "title": "Country (ISO-2, e.g. CN, IN, VN)", "description": "ISO-2 country code of the supplier (e.g. CN, IN, VN, MX). Required to enable import refusal lookup." }, "product_category": { "type": "string", "title": "Product category", "description": "Primary product category. Used to scope recall and enforcement queries to the relevant FDA product domain.", "enum": [ "food", "dietary_supplement", "pharmaceutical", "cosmetic", "medical_device", "veterinary", "seafood", "produce", "all" ] }, "internal_id": { "type": "string", "title": "Your internal supplier ID (passed through)", "description": "Optional internal reference ID. Passed through unchanged in the output for correlation with your own supplier records." } }, "required": [ "name" ] } }, "mode": { "title": "Mode", "enum": [ "screen", "monitor" ], "type": "string", "description": "screen = one-time check. monitor = scheduled run, alert only when a firm's status changes.", "default": "screen" }, "product_categories": { "title": "Filter alerts by product category", "type": "array", "description": "Optional. Narrows alert/refusal matching to these categories.", "items": { "type": "string", "enum": [ "food", "dietary_supplement", "pharmaceutical", "cosmetic", "medical_device", "veterinary", "seafood", "produce", "all" ] }, "default": [ "all" ] }, "include_removed_alerts": { "title": "Include historically removed alerts", "type": "boolean", "description": "If true, includes past (resolved) import alerts as yellow flags.", "default": false }, "min_risk_score_alert": { "title": "Minimum risk score to trigger an alert (monitor mode)", "minimum": 0, "maximum": 100, "type": "integer", "description": "Only send a notification when risk score >= this value.", "default": 30 }, "notify_email": { "title": "Notification email (monitor mode)", "type": "string", "description": "Optional. Where to send change alerts. Requires RESEND_API_KEY." } } }, "runsResponseSchema": { "type": "object", "properties": { "data": { "type": "object", "properties": { "id": { "type": "string" }, "actId": { "type": "string" }, "userId": { "type": "string" }, "startedAt": { "type": "string", "format": "date-time", "example": "2025-01-08T00:00:00.000Z" }, "finishedAt": { "type": "string", "format": "date-time", "example": "2025-01-08T00:00:00.000Z" }, "status": { "type": "string", "example": "READY" }, "meta": { "type": "object", "properties": { "origin": { "type": "string", "example": "API" }, "userAgent": { "type": "string" } } }, "stats": { "type": "object", "properties": { "inputBodyLen": { "type": "integer", "example": 2000 }, "rebootCount": { "type": "integer", "example": 0 }, "restartCount": { "type": "integer", "example": 0 }, "resurrectCount": { "type": "integer", "example": 0 }, "computeUnits": { "type": "integer", "example": 0 } } }, "options": { "type": "object", "properties": { "build": { "type": "string", "example": "latest" }, "timeoutSecs": { "type": "integer", "example": 300 }, "memoryMbytes": { "type": "integer", "example": 1024 }, "diskMbytes": { "type": "integer", "example": 2048 } } }, "buildId": { "type": "string" }, "defaultKeyValueStoreId": { "type": "string" }, "defaultDatasetId": { "type": "string" }, "defaultRequestQueueId": { "type": "string" }, "buildNumber": { "type": "string", "example": "1.0.0" }, "containerUrl": { "type": "string" }, "usage": { "type": "object", "properties": { "ACTOR_COMPUTE_UNITS": { "type": "integer", "example": 0 }, "DATASET_READS": { "type": "integer", "example": 0 }, "DATASET_WRITES": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_READS": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_WRITES": { "type": "integer", "example": 1 }, "KEY_VALUE_STORE_LISTS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_READS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_WRITES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_INTERNAL_GBYTES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_EXTERNAL_GBYTES": { "type": "integer", "example": 0 }, "PROXY_RESIDENTIAL_TRANSFER_GBYTES": { "type": "integer", "example": 0 }, "PROXY_SERPS": { "type": "integer", "example": 0 } } }, "usageTotalUsd": { "type": "number", "example": 0.00005 }, "usageUsd": { "type": "object", "properties": { "ACTOR_COMPUTE_UNITS": { "type": "integer", "example": 0 }, "DATASET_READS": { "type": "integer", "example": 0 }, "DATASET_WRITES": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_READS": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_WRITES": { "type": "number", "example": 0.00005 }, "KEY_VALUE_STORE_LISTS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_READS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_WRITES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_INTERNAL_GBYTES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_EXTERNAL_GBYTES": { "type": "integer", "example": 0 }, "PROXY_RESIDENTIAL_TRANSFER_GBYTES": { "type": "integer", "example": 0 }, "PROXY_SERPS": { "type": "integer", "example": 0 } } } } } } } } } } ```