Get an email when the FDA posts a new warning letter

We check the FDA's warning letters page every day and email you when new letters go up. Your first alert is free.

Checked once a day. One free alert, then it stops. No card.

Latest warning letters on fda.gov

What is an FDA warning letter?
A letter the FDA sends a company when an inspection or review finds significant violations, such as manufacturing (CGMP) failures, adulteration or misbranding. The company is asked to respond within 15 working days, and the FDA publishes the letter on its warning letters page.
Is the alert free?
Yes. We check the FDA's list once a day and send one email when new letters are posted. No card. After that alert, or after 30 days with nothing new, the alert stops. Keeping it going starts at $5 a month.
How soon will I hear about a new letter?
Within a day of the FDA posting it. The FDA posts letters in weekly batches, so the free alert usually arrives within a week of signing up.
Does it cover Form 483s?
No. A Form FDA 483 lists an investigator's observations at the end of an inspection, and the FDA does not post 483s on the warning letters page. A warning letter often follows when a company's response to a 483 falls short.
Can I get alerts for one company or one FDA center only?
Not on the free alert, which covers every new letter. On any plan you can add a condition such as "only letters from CDRH" and we hold back the rest. See pricing.