FDA Warning Letters, Recalls & Enforcement Monitor

Track FDA warning letters and drug, device, and food recalls in one normalized feed. Filter by company, subject keywords, issuing office, and date; extract full letter text as clean, LLM-ready markdown with 21 CFR citations pulled out automatically; and run it on a Schedule in delta-only mode to get alerted the moment the FDA takes action against a company you care about.

Regulatory-intelligence services charge thousands per year for this data. This Actor gets it straight from FDA.gov and openFDA — official, public-domain sources — for cents.

How to monitor FDA warning letters

1. Pick your sources: warning letters, drug recalls, device recalls, food recalls.
2. Filter by company name (e.g. a competitor or supplier), subject keywords (CGMP, sterility, listeria, 510(k)), or date range.
3. Turn on Delta only and create an Apify Schedule — every run returns only enforcement actions that are new since the last run. Wire the dataset into Slack, email, or your own pipeline with any Apify integration.

What you get

Each record is one dataset item, normalized across warning letters and recalls:

Field	Description
recordType	warning-letter, drug-recall, device-recall, food-recall
company	Letter recipient or recalling firm
issuedAt	Letter issue date / recall report date
subject	Letter subject (e.g. "CGMP/Adulterated") or product description
classification	Recall class: Class I, II, or III
cfrCitations	Extracted 21 CFR citations (e.g. 21 CFR 211.22(d))
fullTextMarkdown	Complete letter as clean markdown (when enabled)
letterUrl	Link to the original letter on FDA.gov
isNew	Whether this record is new since the last run

Who uses this

• Pharma / medical device regulatory affairs — track FDA actions against competitors, suppliers, and CMOs
• Quality & compliance teams — feed warning-letter trends (by CFR citation) into audit prep
• Food safety teams — real-time recall monitoring by product keyword
• Investors & analysts — FDA enforcement as a signal on public companies
• AI agents — query FDA enforcement directly via MCP

Use as an MCP server (AI agents)

The Actor runs in Standby mode as a streamable-HTTP MCP server via mcp.apify.com:

• search_fda_enforcement — search letters + recalls with company/keyword/date filters
• get_warning_letter_markdown — any warning letter as clean markdown with CFR citations

Pricing

Pay per event — you only pay for what you extract:

Event	Price
Actor start	$0.005
Enforcement record	$0.002
Letter full text (markdown + CFR citations)	$0.015

A daily delta-only monitor typically costs well under $0.05 per run — most runs return only a handful of new records.

FAQ

Where does the data come from? Warning letters come from FDA.gov's official listing; recalls come from the openFDA enforcement API. Both are US-government public-domain data.

How complete is it? The warning-letter feed covers the full FDA archive (thousands of letters, updated as FDA publishes). Recalls cover drug, device, and food enforcement reports back to 2004.

Do I need an API key? No. Optionally add a free openFDA key to raise rate limits for very large pulls.

Can I get only NEW enforcement actions? Yes — that's delta-only mode. The Actor remembers what it already delivered for your exact filter combination.