FDA Warning Letters Monitor: By Company & Subject

What does FDA Warning Letters Monitor do?

FDA Warning Letters Monitor returns the warning letters that FDA publishes on fda.gov, filtered by company, issuing office, subject and date. For each letter it can also read the letter itself: the start of the text, the product line and the 21 CFR regulations the letter cites. No key, no login, no proxy: it uses the same public list that the FDA page shows.

Each row has:

• company and issuing office (CDER, CDRH, CBER, Human Foods Program, CVM, CTP ...)
• letter date and posted date
• subject (for example CGMP/Finished Pharmaceuticals/Adulterated)
• product type (drugs, medical devices, food ...) and where it came from
• response letter and close-out letter flags, with dates and links
• the letter link
• the first 800 characters of the letter text (without the date and salutation)
• the cited regulations, such as 21 CFR 211.22 or 21 CFR Part 820

Who is it for?

• Pharma, device and food quality and regulatory teams: new warning letters to competitors, suppliers and contract manufacturers, with the regulations cited.
• Supplier risk and procurement teams: check a list of supplier names against FDA warning letters, with fuzzy name matching.
• Investors and analysts: spot enforcement against listed companies early, and see whether a letter was closed out.
• Law firms and consultants: the subject, office and cited regulations for each letter, ready for a spreadsheet.

Related Actors from the same developer: US Product Recalls Monitor (FDA and CPSC recalls, often the next step after a warning letter) and OSHA & EPA Violation Monitor (workplace and environmental enforcement for the same company names).

How to use it

1. Click Start with the default input: the 5 newest letters of the last 30 days, with the letter text. This takes about 3 minutes because of FDA's crawl delay (see below).
2. Add filters: company names, issuing offices (CDER, CDRH ...), subject keywords (CGMP, adulterated, misbranded, data integrity), a letter date window.
3. For a fast list without letter text, turn Read each letter off: 100 letters take about 30 seconds.
4. Schedule it weekly with a short window (for example letters from 14 days). Letters appear on fda.gov a few days to weeks after their date.

Why is it slow?

FDA's robots.txt asks crawlers without their own entry to wait 30 seconds between requests. This Actor sends one request at a time and waits 30 seconds between them. Reading a letter's text needs one request per letter, so it adds about 30 seconds per letter. The list itself comes 100 letters per request. Plan runs accordingly: 25 letters with text take about 13 minutes; 1,000 letters without text take about 5 minutes.

Input example

{
    "companyNames": ["Fresenius Kabi", "Teva"],
    "issuingOffices": ["CDER", "CDRH"],
    "subjectKeywords": ["CGMP", "data integrity"],
    "lettersFrom": "90 days",
    "includeLetterText": true,
    "maxResults": 25
}

Field	Meaning
companyNames	Fuzzy: legal suffixes (Inc, LLC, Ltd), plurals and one typo in long words are ignored; all words must appear in the company name.
issuingOffices	Part of an office name, or CDER, CDRH, CBER, CVM, CTP, HFP, OPDP, OII.
subjectKeywords	A letter matches if its subject line contains any keyword.
lettersFrom, lettersTo	2026-09-01 or relative (30 days). Default: the last 30 days.
includeLetterText	Read each letter page (text start, product, cited regulations). Default on.
maxResults	Up to 1,000 letters, newest first (default 25).

Output example

Real output of a local run on 7 October 2026 with the default input (5 letters, last 30 days):

Company	Issuing office	Letter date	Subject	Product	Cited
Terramed	CDER	2026-10-01	Unapproved New Drugs	Drugs	21 CFR 201.128
DesBio/Deseret Biologicals, Inc.	CDER	2026-10-01	Unapproved New Drugs	Drugs	21 CFR 201.128
Aidance Scientific, Inc.	CDER	2026-10-01	Unapproved New Drugs	Drugs	21 CFR 201.128
The Platinum Healthcare LLC	CDER	2026-10-01	Unapproved New Drugs	Drugs	21 CFR 201.128
Graceful Touch, LLC	CDER	2026-10-01	Unapproved New Drugs	Drugs	21 CFR 201.128

A CGMP letter in full (letter text shortened):

{
    "company": "Fresenius Kabi USA LLC",
    "issuingOffice": "Center for Drug Evaluation and Research (CDER)",
    "letterDate": "2026-09-22",
    "postedDate": "2026-09-29",
    "subject": "CGMP/Finished Pharmaceuticals/Adulterated",
    "productType": "Drugs",
    "productTypeSource": "letter",
    "hasResponseLetter": false,
    "isClosedOut": false,
    "closeoutLetterDate": null,
    "letterUrl": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fresenius-kabi-usa-llc-733107-09222026",
    "letterTextStatus": "fetched",
    "letterTextPreview": "This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) inspection of your facility. Promptly address the violations described herein withou…",
    "citedRegulations": ["21 CFR Part 210", "21 CFR Part 211", "21 CFR 211.192", "21 CFR 211.113(b)", "21 CFR 211.110(a)", "21 CFR 211.42(c)(10)", "21 CFR 211.34"]
}

Checked live on 7 October 2026: the default input (6 requests, 2 minutes 31 seconds), a fuzzy company search over 8 months with the letter text off (Deseret Biologicals matched DesBio/Deseret Biologicals, Inc.; 5 list pages, 2 minutes), and a CDER + CGMP filter.

How much does it cost?

This Actor uses pay per event:

Event	Price
Letter returned (one row each)	$0.003
Info rows, error rows and "no results" rows	free

• 100 letters cost $0.30. The default run (5 letters) costs $0.015.
• The FDA list is free. Apify also charges a tiny standard start fee per run, and compute time counts: because of the 30-second delay, a run with letter text uses more run time than most Actors (about 0.5 minutes per letter at 256 MB).
• Set Maximum cost per run and the Actor stops when it is reached.

Limitations

• Only letters that FDA has posted, in the order FDA lists them. A letter is usually posted a few days to a few weeks after its date.
• Slow by design: one request every 30 seconds, as fda.gov's robots.txt asks (see above).
• Product type is derived: from the letter page when it is read, else from the issuing office, else from the subject line, and it can be empty. productTypeSource says which.
• Cited regulations are read from the letter text with patterns (21 CFR 211.22(d), 21 CFR Parts 210 and 211 ...). Other regulations (for example 9 CFR or 42 CFR) are not listed, and an unusual spelling can be missed.
• The letter text starts after the date and the salutation, because the salutation names the recipient, which this Actor does not return.
• Subject keywords match the subject line only, not the whole letter.
• The listing endpoint is the one fda.gov's own page uses; if FDA changes the page, the Actor returns a free error row until it is updated.
• Company search over many years reads many list pages (about 30 seconds per 100 letters).

FAQ

Is this official data?

Yes. It is FDA's own published warning letter list and letter pages. FDA says the content of fda.gov is in the public domain.

Does this use openFDA?

No. openFDA does not offer warning letters. The Actor reads the list that FDA publishes on fda.gov, and follows its robots.txt crawl delay.

Can I check a supplier list?

Yes: put the names in companyNames. The match is fuzzy and the row says which name matched (matchedCompany). Use a long lettersFrom (for example 3 years) and turn the letter text off to keep it quick.

What do the response and close-out flags mean?

FDA lists a response letter when the company's response is posted, and a close-out letter when FDA has determined the violations were addressed. The row shows the date and link of each.

Does it return people's names?

No. The recipient named in a letter's salutation is not returned, and the text starts after it. The company names, offices and subjects are as FDA publishes them.

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