FDA Warning Letters

Data through 30 October 2026.

Warning letters from CDER, CDRH and CBER

2,107

Newest letter

30 October 2026

Coverage starts

2017

Snapshot rebuilt

6 November 2026

Warning letters by year

2026 (to 30 October 2026)

352

2025

413

2024

209

2023

180

2022

147

2021

191

2020

228

2019

147

2018

127

2017

112

2015

1

By issuing office

CDER

1,584

CDRH

436

CBER

87

Deficiency tags

Unapproved new drug

852 letters

Quality unit

454 letters

Labeling

349 letters

510(k) required

302 letters

Supplier controls

298 letters

Process validation

276 letters

Marketing claims

266 letters

Stability

262 letters

Batch records

247 letters

Out-of-specification

229 letters

Misbranded and adulterated are left out because they are statutory conclusions that appear in more than half of all letters. A letter can carry several tags.

Close-outs and escalation

Letters with a published close-out letter

44

Letters whose establishment later faced an injunction or seizure

4

Close-out status is only known for letters FDA's table covers, so the first figure is a floor and not a rate.

Source: FDA's warning letter pages, listed in FDA's sitemap and read into a snapshot by a script. Letters from the drug, device and biologics centers only. Tags are this tool's keyword matches on the letter text.

A warning letter is FDA's notice to a company or person that it has found what it believes are significant violations of federal requirements. FDA describes the letter as identifying the concern, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. It asks for a response within a stated time and gives the recipient a chance to fix the problem or explain why FDA is wrong.

FDA publishes its warning letters on FDA.gov. It offers no data download or API for them, only a table and one web page per letter. This tool is a searchable copy of those pages. A script reads FDA's sitemap, which lists every letter page, fetches each one, and builds the snapshot the search runs on. The script runs about once a week, and the data block above shows when it last ran.

The scope is letters from the drug, device and biologics centers: CDER, CDRH and CBER, from 2017 on. FDA's sitemap lists almost nothing earlier, so older letters are not here. Tobacco, food and veterinary letters are left out. Tobacco alone is about a quarter of everything FDA publishes, and it is a different regulatory world from the one a drug or device quality role works in.

This is a database of warning letters, not of every FDA enforcement step. Untitled letters, Form 483s and inspection reports are separate records. Letters about drug promotion, including OPDP's untitled letters, are in the OPDP letter search. The inspection search covers inspection outcomes.

Letter date

The date on the letter, read from the letter's own address on FDA.gov. FDA posts a letter after it is sent, so the posting date is later.

Company

The recipient firm as FDA titles the letter. Companies change names and appear under several.

Issuing office

CDER for drugs, CDRH for devices, CBER for biologics. The center whose division wrote the letter.

Product type

FDA's product label for the letter, such as Drugs or Medical Devices.

Recipient

The named person the letter is addressed to, usually a chief executive or head of quality.

Deficiency tags

Labels this tool adds by scanning each letter's text for what it cites, such as data integrity, aseptic processing or design controls. They are ours, not FDA's.

Close-out status

Closed out, with the date, or not known. See the close-out section for why unknown is the common answer.

Establishment ID (FEI)

FDA's establishment identifier, taken from FDA's Data Dashboard where it matches the letter. It identifies the site, which a company name cannot.

Later enforcement

An injunction or seizure recorded against the same establishment after the letter. It is rare.

Type in the search box, pick filters, or both. Everything runs in your browser against the snapshot, so nothing you type is sent anywhere.

• By company. A company name matches the firm named on the letter. Try a short form, such as the group name, to catch subsidiaries.
• By deficiency. The deficiency filter lists the tags. Pick one to see every letter that cites that problem, for example data integrity, aseptic processing or design controls.
• By office and year. Narrow to devices or drugs, or to one year.
• By words in the letter.A search for a phrase such as "media fill" uses a full-text index of every letter. It loads the first time you need it.
• By close-out. The closed-out filter shows letters with a published close-out letter.

Every search has its own address, so you can paste the link into a report. Each result links to the letter on FDA.gov.

Letters follow a common shape. Knowing it speeds up reading.

• The inspection.The opening paragraph says what FDA inspected, where and on which dates, and what the firm makes. For a device firm it often explains why the product is a device under section 201(h) of the FD&C Act.
• The statutory conclusion. The letter says the product is adulterated or misbranded under a section of the Act. A device made under a failed quality system is adulterated under section 501(h). A drug made under failed current good manufacturing practice is adulterated under section 501(a)(2)(B). These conclusions appear in more than half of all letters, which is why this tool does not show them as deficiency tags.
• The numbered violations. The body of the letter. Each one quotes the regulation, such as a section of 21 CFR part 211 for drugs or part 820 for devices, then states what the investigator saw. Where the firm answered the Form 483 first, the letter says whether FDA found the answer adequate.
• The demand. Most letters ask for a written response within 15 business days, listing what the response must cover. The letter states its own deadline, and that deadline is the one that counts.
• The warning. The letter says the list of violations is not exhaustive, and that failure to correct may lead to enforcement without further notice. FDA names seizure and injunction as examples.

The number in the letter heading and address, such as 717576, is the MARCS-CMS case number, FDA's tracking number for the matter.

FDA may issue a close-out letter once it has evaluated the corrective actions a firm took in response to a warning letter. The program applies to letters issued on or after 1 September 2009.

A close-out letter does not follow promises. FDA says the corrective actions must actually have been made and verified, and that the usual standard is a follow-up inspection. If the violations are not correctable by their nature, no close-out letter issues. The FDA office that wrote the warning letter writes the close-out. FDA describes the program on its warning and close-out letters page.

This tool shows close-out status only where FDA's own table carries a date. The letter pages do not show it. That means "not known" is the honest answer for most letters, and it must not be read as "never closed out". For the same reason the page reports no overall close-out rate.

Most warning letters follow an inspection. At the end of an inspection the investigator may issue a Form FDA 483 listing observations. The firm can respond to it, and the response is considered when FDA decides whether to send a warning letter. The glossary covers the Form 483 response and the warning letter response.

After the letter, the firm responds, FDA reviews the answer and may re-inspect, and FDA may issue a close-out letter. If the firm does not correct, FDA can escalate. The later enforcement field here marks letters where the same establishment later faced an injunction or seizure.

If you are checking a supplier or acquisition target, read the letter, then look at the inspection record with the inspection search and the recalls with the recall search.

• It is a snapshot. It is rebuilt about once a week. A letter FDA posted in the last few days may be missing, and the data block above shows the date of the newest letter in it.
• It is not every letter.Only CDER, CDRH and CBER letters from 2017 on are in scope. FDA's own site may hold older ones.
• Tags are keyword matches. A tag means the letter text contains a phrase we associate with the topic. A letter can mention a topic without citing it as a violation, and a violation can be worded in a way the patterns miss.
• Letters change after posting. FDA warns that later contact between FDA and the recipient may change the regulatory status of issues in a letter. A letter alone does not show where things stand now.
• The full text is on FDA.gov. The tool reproduces a short excerpt and the tags, not the letter.

FDA's table. FDA's warning letters page lists letters in a searchable table with the company, issuing office and subject.

FDA Data Dashboard.FDA's Compliance Actions dashboard carries establishment numbers and later actions such as injunctions. Its API requires credentials from FDA's OII Unified Logon, which is why this tool does not offer a public API.

The snapshot. The file this tool searches is public at /data/warning-letters.json. Each letter is a row of values and the header lists the office, product and tag names the rows index into.

FOIA. For records FDA has not posted, FDA directs requests to its Division of Freedom of Information.

What is an FDA warning letter?

FDA's written statement that it considers a company in violation, naming the specific regulations breached. It is issued after an inspection classified OAI, official action indicated, or on other evidence, and it is published on FDA's website.

How long do I have to respond?

Ordinarily 15 working days from receipt. The letter states its own deadline, so follow what it says rather than the general rule.

What is a closeout letter?

FDA issues one once it has verified the violations were addressed, ordinarily after a follow-up inspection. Closeout letters are published too, and the filter here shows which letters have one.

Why do so few letters have a closeout?

A closeout requires FDA to verify the corrections, which usually means a re-inspection, so it takes time and many letters never receive one. Use the closeout filter to see the split for any company or year yourself rather than trusting a single headline number.

How many letters does this cover?

2,107 letters issued by CDER, CDRH and CBER from 2017 to 30 October 2026, taken from FDA's own sitemap, which lists every published letter. Tobacco, food and veterinary letters are excluded: tobacco alone is about a quarter of the letters FDA publishes and would drown everything an RA or QA reader is looking for.

What are the deficiency tags?

Each letter's full text is scanned at build time for the things letters actually turn on: data integrity, aseptic processing, cleaning validation, out-of-specification results, design controls, supplier controls and so on. Misbranded and adulterated are searchable but not shown, because they are statutory conclusions that appear in over half of all letters and say nothing about the specific problem.

Where is the full letter text?

On FDA.gov, and every result links straight to its own letter. FDA serves letter bodies only as individual web pages rather than as data, so the text is not reproduced here.

Are FDA warning letters public?

Yes. FDA posts its warning letters on FDA.gov, one page per letter, after they are sent. Close-out letters are posted too. FDA notes that later contact with the recipient may have changed the status of the issues a letter describes.

How often is the warning letters database updated?

A script rebuilds the snapshot about once a week from FDA's sitemap and letter pages, and the data block shows when it last ran. The newest letter in it is dated 30 October 2026. A letter FDA posted in the last few days may not be in yet.

Is there an API or bulk download for FDA warning letters?

FDA publishes no public API or data file for warning letters, only its web table and one page per letter. FDA's Data Dashboard has a compliance actions API, but it needs credentials from FDA's OII Unified Logon. The snapshot this tool searches is public at arca.inc/data/warning-letters.json.