FDA Warning Letters Monitor

Get every new FDA warning letter the day it is posted. This actor reads the warning letters the FDA publishes on fda.gov and returns each one as a clean row: the company, the issuing office and program, the subject, whether it has been closed out, and a link to the letter itself. Filter by program or keyword, run it on a schedule, and get a Slack digest of only the letters that are new since your last run.

No API key. You only pay for letters you actually get back.

Who uses this

• Regulatory affairs and quality teams tracking enforcement in their sector and against named competitors and contract manufacturers.
• Consultants and law firms in FDA-regulated industries who need to spot new letters fast and reach affected companies.
• Pharma, device, food and supplement suppliers screening partners and CDMOs for compliance history.
• Investors and analysts watching enforcement as a risk signal.
• Data teams who want the warning-letters feed as tidy JSON instead of scraping the table by hand.

What you get

One record per warning letter:

Field	Description
companyName	Company the letter was issued to
issueDate	Date the letter was issued
postedDate	Date the FDA posted it publicly
issuingOffice	The FDA office that issued it (e.g. CDER)
program	Program in plain words: Drugs, Medical devices, Food, Biologics, Tobacco, Veterinary, Imports
subject	The violation subject line
excerpt	Short excerpt, where the FDA provides one
letterUrl	Link to the full letter
responseLetterUrl	Link to the company's response, if published
closeoutLetterUrl / hasCloseout	Close-out letter and whether the case is closed
isNew	In monitor mode, whether the letter is new since the last run

Input examples

All new drug and device letters from the last 60 days:

{
  "programs": ["drugs", "medical-devices"],
  "sinceDays": 60,
  "maxLetters": 500
}

Scheduled monitor with a Slack alert on new letters mentioning data integrity:

{
  "keywords": ["data integrity", "CGMP"],
  "sinceDays": 3,
  "monitorMode": true,
  "webhookUrl": "https://hooks.slack.com/services/XXX/YYY/ZZZ"
}

Watch a specific company or contract manufacturer:

{
  "keywords": ["Fareva"],
  "sinceDays": 1825
}

How monitor mode works

Turn on monitorMode and schedule the actor (daily is typical). The first run records what is already posted as a baseline. Every run after that returns, and charges for, only letters that are new since the previous run, and posts them to your webhook if you set one. A daily run costs you a handful of new letters, not the whole archive each time.

Pricing

Pay per event, no subscription. Users on higher Apify plans get automatic discounts.

Event	Price	When
Run started	$0.005	Flat, once per run
Letter found	$0.01	Per new/matched warning letter returned with its data
Digest sent	$0.03	Monitor mode only, per Slack/webhook digest actually posted

Platform usage is included in the price. In monitor mode the persistent seen-set means you are never billed twice for the same letter, so a quiet scheduled run only pays the small run fee.

FAQ

Where does the data come from? The FDA's own published warning letters on fda.gov. These are public enforcement records.

Do I need an account or API key? No. Nothing to set up.

How fresh is it? Letters appear here as soon as the FDA posts them, which is the same list the public warning-letters page shows.

Can I filter to my industry? Yes, use programs for drugs, devices, food, biologics, tobacco, veterinary or imports, and keywords to narrow further by company or subject.

Does it include close-out letters? Yes. When the FDA closes a case it posts a close-out letter, and the hasCloseout flag and closeoutLetterUrl tell you.

How far back can I go? Up to five years with sinceDays. The FDA keeps several years of letters online.

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