FDA warning letter search

Filter by what the letter turned on

FDA's own table gives you a company, a date and a classification string. That tells you a letter was about CGMP. It does not tell you whether the problem was an audit trail, a media fill, a cleaning procedure or a supplier nobody qualified.

The deficiency filter here reads the full text of every letter and tags what it actually cites. Misbranded and adulterated stay out of the tags on purpose: they are statutory conclusions, present in over half of all letters, and they crowd out the one that matters.

Closeout status is shown where FDA publishes it, and marked unknown where it does not, rather than being reported as a letter nobody ever closed. For the same reason there is no headline closeout percentage anywhere on this page: it is only knowable for the recent letters, so a rate across the whole set would be a firmer claim than the data supports.

What a warning letter is, what the response has to contain and how close-out actually works is in the glossary, along with the Form 483 that usually precedes one.

Frequently asked questions

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?

1,976 letters issued by CDER, CDRH and CBER between 2015 and today, taken from FDA's own sitemap, which lists every published letter. Tobacco, food and veterinary letters are excluded: tobacco alone is 1,803 of the 7,326 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.