The warning letter has two dates

A CDRH warning letter carries two dates that are easy to conflate and expensive to conflate wrong: the date FDA issued it, and the date FDA posted it publicly. They are rarely the same day, and the letter does not explain the gap. Neither does the subject line, which reads like a sentence and is actually closer to a taxonomy. Both are worth reading correctly.

The date that starts your clock

The compliance clock does not start when the letter appears on fda.gov. It starts when the recipient receives it — close to the letter’s issue date, not its posting date — and FDA’s Regulatory Procedures Manual sets out the standard closing language nearly every warning letter carries: a written response describing corrective action, generally due within fifteen working days of receipt. That number is customary, not a statute, and FDA has departed from it: in late 2025 two device firms received thirty business days instead of fifteen, stated plainly in their own letters. What survives both cases is the same instruction — read the deadline the letter itself states, and count from receipt, not from whenever you happened to notice the letter existed.

The date that is not the clock

The posted date answers a different question: when did this become public, and therefore visible to a competitor, a journalist, or you, if the letter was never addressed to you. FDA’s warning letter database carries both dates as distinct fields for exactly this reason — conflating them produces two different errors. Treat the posted date as the clock and you may believe a firm has more time than it does. Treat the issue date as when the public could see it and you may believe you missed something that has not, in fact, been published yet. FDA Radar keeps both fields separate in every letter it ingests, because a monitoring product that reported one date as the other would be wrong on the one detail this product exists to get right.

The subject line is a taxonomy, not a sentence

Read a CDRH warning letter’s subject line closely and it is not prose — it is a short list of violation categories separated by slashes, drawn from a small, recurring vocabulary FDA reuses letter after letter: Quality System/Medical Device/Adulterated, or some neighbouring combination. Read one letter and it is a label. Split a quarter’s worth of subject lines on that slash, tally the categories, and the label becomes data: which failure mode CDRH is currently finding often enough to write about repeatedly, in your corner of the industry, this quarter rather than last.

You do not need this product to run that exercise once. Filter FDA’s warning letter database to the Center for Devices and Radiological Health, sort by posted date, and pull the last thirteen weeks in your device class. For each letter, note the issue date rather than the posted date, and split the subject into its categories. What comes out is not gossip about individual firms — it is, in miniature, CDRH’s enforcement agenda for your quarter, built entirely from language FDA itself chose to put in a subject line.

One warning letter is a fact about one firm. A quarter of them, read as a set, is a fact about what FDA is looking for.

What this is not

None of this tells you what to do if a letter names you, a competitor, or a supplier. Reading the enforcement theme in your device class is a monitoring habit; deciding what it implies for your quality system, your risk file, or your own submission is a regulatory judgment for a professional looking at your specific facts — this post, like the rest of Signals, is intelligence about how to read the record, never advice about what your record should say.

FDA Radar ingests CDRH warning letters, keeps issue date and posted date as separate fields, and parses the subject line into its component violation themes automatically — what reaches a reviewer is the structured version of the above; what the reviewer still decides is whether it is material to you. See what we source and how often for the rest of the pipeline.