FDA Warning Letter Watch — Device & Drug Enforcement Tracker

Monitor FDA device and drug enforcement actions in real-time. Track warning letters, recalls, and safety alerts with classification data, recalling firms, product descriptions, and severity scores — all from the official openFDA API as structured JSON.

What data can you get?

Device Enforcement — Track medical device recalls and enforcement actions. Each record includes the recalling firm, product description, reason for recall, FDA classification (Class I/II/III), distribution pattern, and recall status.

Drug Enforcement — Monitor pharmaceutical enforcement actions including product recalls, market withdrawals, and safety alerts. Get the drug name, recalling firm, reason, and classification.

Use cases

• Medical device companies — Monitor for competitor recalls and industry enforcement trends
• Hospital quality teams — Get alerts when devices in your inventory are recalled
• Pharma compliance — Track enforcement actions across drug categories relevant to your portfolio
• Healthcare investors — Assess regulatory risk for medical device and pharma stocks
• Regulatory consultants — Build enforcement trend reports for FDA-regulated clients
• Quality assurance — Monitor for patterns in recall reasons (cGMP violations, contamination, labeling)

How to use

1. Optionally set keywords (e.g., ["contamination", "cGMP"]) to filter by reason or product
2. Set since date to limit to recent enforcement actions
3. Filter by severity (critical, high, medium, low) based on FDA classification
4. Run the actor and get structured enforcement data

Example input

{
  "keywords": ["contamination", "cGMP"],
  "since": "2025-01-01",
  "severity": "high",
  "maxResults": 100
}

Example output

{
  "source": "fda-device-enforcement",
  "itemId": "Z-0192-2025",
  "itemName": "Medtronic Inc.",
  "itemSummary": "Software defect may cause incorrect insulin delivery calculations",
  "severity": "high",
  "score": 8.0,
  "publishedAt": "2025-09-20T00:00:00.000Z",
  "url": "https://api.fda.gov/device/enforcement.json",
  "tags": ["fda", "enforcement", "warning-signal"],
  "scrapedAt": "2026-02-14T12:00:00.000Z"
}

Data sources

• openFDA API — Official FDA open data covering device and drug enforcement actions
• Data refreshed in real-time with every run

Pricing

Pay-per-event pricing. You only pay for what you use:

• $0.50 per actor start
• $0.0035 per enforcement record

Example: Fetching 200 recent FDA enforcement actions costs $0.50 + $0.70 = $1.20 total.

Integrations

Works with all Apify integrations: webhooks, API, Zapier, Make, Google Sheets, and more. Schedule daily runs for continuous FDA enforcement monitoring.

Tips

• Schedule daily runs for regulatory teams. FDA publishes new enforcement actions on a rolling basis, and daily monitoring ensures timely awareness of recalls affecting your products or industry.
• Filter by severity to focus on what matters. Class I (mapped to high/critical) represents the most serious recalls — situations where there's a reasonable probability of adverse health consequences. Class III (low) covers minor labeling issues.
• Search by firm name to monitor specific companies. Pass competitor names as keywords to track their enforcement history.
• Combine with the Recall Compliance Watch actor for complete FDA coverage. This actor focuses on device and drug enforcement, while Recall Compliance Watch adds food recalls for a full FDA picture.
• Use webhooks to push results to your quality management system (QMS) or compliance dashboard for automated triage.