# FDA Compliance Monitor — Recalls, CRLs & Safety Signals (`brick_joey_yto/fda-compliance-monitor`) Actor

Monitor the official openFDA API — recalls, FAERS adverse events, drug approvals, device 510(k)/PMA decisions and Complete Response Letters. Company watchlists across every FDA dataset.

- **URL**: https://apify.com/brick\_joey\_yto/fda-compliance-monitor.md
- **Developed by:** [William Billings](https://apify.com/brick_joey_yto) (community)
- **Categories:** Lead generation, Business, Automation
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

$1.00 / 1,000 result rows

This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events.

Learn more: https://docs.apify.com/actors/running/actors-in-store.md#pay-per-event

## What's an Apify Actor?

An Actor is a serverless cloud program that runs on the Apify platform. It has two run modes.
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.

Apify vocabulary and the platform model are defined once, in the agent quickstart at https://apify.com/agents.md.

## 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.

Do not guess an integration path. Every one of them is in the agent quickstart at https://apify.com/agents.md: the Apify MCP server, Agent Skills with the Apify CLI, the JavaScript and Python clients, the REST API, and the account-free path for an agent with no human to sign in. It also carries the rule on stating cost before the first paid run.

For examples already wired to this Actor's own input schema, see the [API](#api) section below.

Each client library has reference documentation the quickstart does not restate: [JavaScript/TypeScript](https://docs.apify.com/api/client/js/docs.md) (`npm install apify-client`) and [Python](https://docs.apify.com/api/client/python/docs.md) (`pip install apify-client`).

# README

## FDA Compliance Monitor

Monitor the FDA's own openFDA API for **recalls, adverse events, drug approvals, device clearances, and Complete Response Letters** — compliance intelligence for pharma, biotech, med-device, and regulatory affairs teams.

No API key required. No browser. Pure official FDA data.

### Modes

| Mode | What it returns | Data source |
|---|---|---|
| `recalls` | Drug, food, and device enforcement actions | openFDA enforcement |
| `adverse` | Drug adverse-event reports (FAERS) | openFDA drug/event |
| `approvals` | Drug approval records & submission history | Drugs@FDA |
| `clearances` | Device 510(k) clearances & PMA approvals | openFDA device |
| `crl` | Complete Response Letters — including full letter text | FDA transparency dataset (new 2025) |
| `company` | **One firm's entire FDA footprint** — recalls, CRLs, approvals, devices in one feed | all of the above |

### Example inputs

**Watch a company across every FDA dataset:**

```json
{"mode": "company", "query": "medtronic", "dateAfter": "2025-09-01"}
```

**New Class I drug recalls this month:**

```json
{"mode": "recalls", "productArea": "drugs", "classification": "Class I", "dateAfter": "2025-09-01"}
```

**Serious adverse events for a drug (weekly monitor):**

```json
{"mode": "adverse", "query": "ozempic", "seriousOnly": true, "dateAfter": "2025-09-22"}
```

**A competitor's Complete Response Letters:**

```json
{"mode": "crl", "query": "biogen"}
```

**Latest device clearances:**

```json
{"mode": "clearances", "deviceType": "510k", "dateAfter": "2025-09-01"}
```

### Monitoring pattern

Schedule this actor weekly with `dateAfter` = your last run date and a `query` or `company` watch — each run emits only what changed. Ideal for:

- **Competitive intelligence** — rival CRLs, recalls, and approvals as they publish
- **Safety signals** — adverse-event streams for your products or a competitor's
- **Regulatory affairs** — recall classifications and warning data by firm
- **Investment research** — CRLs and approval decisions before headlines

### Fields (per record)

Every row carries `recordType` so mixed feeds stay readable: `recall`, `adverse_event`, `drug_approval`, `device_510k`, `pma_approval`, or `complete_response_letter` — plus dates, firm/applicant/sponsor, product details, classification, and the letter text excerpt for CRLs.

### Notes & limitations

- All data comes from the official openFDA API — free, public, no key.
- openFDA search accepts a single filter clause per request; this actor applies additional filters client-side. `adverse` mode without a date range returns the oldest matching reports first (the API does not sort) — always pass `dateAfter` for monitoring.
- FDA datasets lag real-world events (recalls post within days; FAERS reports can lag weeks).
- CRL `textExcerpt` is truncated to 1,500 chars — `fileName` identifies the full PDF on FDA.gov.

### Pricing

Pay-per-event: ~$1 per 1,000 records returned, billed on Apify's current pricing format. No per-run fee.

# Actor input Schema

## `mode` (type: `string`):

recalls = drug/food/device enforcement actions. adverse = drug adverse event reports. approvals = drug approval records (Drugs@FDA). clearances = device 510(k)/PMA decisions. crl = Complete Response Letters. company = combined watchlist across datasets for one firm.

## `query` (type: `string`):

Drug/product/company keyword. Mode-specific: recalls → product or firm, adverse → drug name, approvals → sponsor or brand, crl → company name.

## `productArea` (type: `string`):

Limit recalls to a product type.

## `classification` (type: `string`):

Class I = serious/death risk, Class II = temporary/reversible harm, Class III = unlikely harm.

## `deviceType` (type: `string`):

510(k) = premarket notification clearances. PMA = premarket approvals for high-risk devices.

## `seriousOnly` (type: `boolean`):

Restrict adverse event reports to serious outcomes only.

## `deathsOnly` (type: `boolean`):

Restrict adverse event reports to death outcomes.

## `dateAfter` (type: `string`):

Only records dated on/after this date (YYYY-MM-DD). For monitoring schedules set this to your last run date.

## `dateBefore` (type: `string`):

Only records dated on/before this date (YYYY-MM-DD).

## `maxResults` (type: `integer`):

Maximum rows to return (1–5000).

## Actor input object example

```json
{
  "mode": "recalls",
  "productArea": "all",
  "classification": "all",
  "deviceType": "both",
  "seriousOnly": false,
  "deathsOnly": false,
  "maxResults": 100
}
```

# Actor output Schema

## `results` (type: `string`):

Dataset containing lobbying disclosure records

# 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 '<YOUR_API_TOKEN>' with your token
const client = new ApifyClient({
    token: '<YOUR_API_TOKEN>',
});

// Prepare Actor input
const input = {};

// Run the Actor and wait for it to finish
const run = await client.actor("brick_joey_yto/fda-compliance-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 '<YOUR_API_TOKEN>' with your token.
client = ApifyClient("<YOUR_API_TOKEN>")

# Prepare the Actor input
run_input = {}

# Run the Actor and wait for it to finish
run = client.actor("brick_joey_yto/fda-compliance-monitor").call(run_input=run_input)

# Fetch and print Actor results from the run's dataset (if there are any)
print(f"💾 Check your data here: https://console.apify.com/storage/datasets/{run.default_dataset_id}")
for item in client.dataset(run.default_dataset_id).iterate_items():
    print(item)

# 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start

```

## CLI example

```bash
echo '{}' |
apify call brick_joey_yto/fda-compliance-monitor --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,brick_joey_yto/fda-compliance-monitor"
        }
    }
}
```

The hosted server signs you in with OAuth on first connect, so no API token belongs in this config. Clients without OAuth support can send an `Authorization: Bearer <APIFY_API_TOKEN>` header instead, using a token from API & Integrations in Apify Console (https://console.apify.com/settings/integrations).

## OpenAPI specification

Download the OpenAPI definition: https://api.apify.com/v2/actors/LptYGgy2gC6wpDVZK/builds/5MeZK03kFuqA6ruFr/openapi.json