The published record at a glance
1,703 letters to drug, device and biologics makers since 2021. These counts cover the full dataset; interactive filters apply after the charts load.
| Product type | Letters |
|---|---|
| Drugs | 1,351 |
| Medical Devices | 266 |
| Biologics | 86 |
| Year issued | Letters |
|---|---|
| 2021 | 262 |
| 2022 | 229 |
| 2023 | 234 |
| 2024 | 245 |
| 2025 | 406 |
| 2026 | 327 |
| Regulation | Letters citing it |
|---|---|
| 21 CFR 201.128 | 321 |
| 21 CFR 211.22 | 292 |
| 21 CFR 211.84 | 275 |
| 21 CFR 211.100 | 243 |
| 21 CFR 201.5 | 209 |
| 21 CFR 211.165 | 202 |
| 21 CFR 211.192 | 193 |
| 21 CFR 211.166 | 166 |
| 21 CFR 211.160 | 140 |
| 21 CFR 201.115 | 134 |
Source: Botable FDA Warning Letter Database, 1,703 letters, checked Nov 7, 2026.
Latest from FDA
Summary
The whole record at a glance. Set a filter and your slice draws over it, then pick a view to go deeper.
Letters per month
Warning letters issued per month to drug, device and biologics makers, Jan 2021 to Oct 2026. Peak: 96 in Sep 2025. Dashed line: 12-month average, now 34.6 a month. Full months only. Tap or hover the chart for any month; click a month to filter to it.
Top 3 trends
Sections and clauses with the largest comparable count changes.
Top 5 citations
The CFR sections and ISO clauses cited in the most letters. Click one to filter.
Top 5 issue types
What went wrong, as read from the findings. Click one to filter.
Quality terms in the letters
The bigger the word, the more letters in your filter use it. Click words to filter; picking several finds letters that mention all of them.
What the agency keeps finding
Citations are pulled from the letter text. When a filter is on, the dim bar behind each value is the unfiltered total.
Trends
QMSR took effect February 2, 2026. Related device citations are grouped by topic. Exact references remain available; grouping does not make requirements equivalent.
Letters citing each CFR section or ISO clause, by year. Change compares two periods of your choosing; both counts are shown in every row. Click a row to filter.
Most cited sections and clauses
Letters citing each section. Click a bar to filter; "Details" opens the regulation and its letters.
The findings, in FDA's own words
The most common violation statement for each section, with how many letters state it. Click a statement to read it in full; click the section number to filter.
What went wrong, by issue type
Model-assisted issue types group the letters by quality topic. Supporting FDA passages appear in letter details where available. A letter counts once per type. Click a bar to filter.
Go deeper
The same filter from more angles.
Citation relationships
Size by letters shows exact CFR sections and ISO clauses. Size by change groups related device references into topics; new-only and non-comparable topics are excluded. A line joins references found in the same letter. Counts are citation patterns, not regulatory equivalence or industry-wide compliance.
Where in the US
Letters by the state of the addressed facility. Brighter is more. Click a state to filter.
Top states
The same counts, ranked. Click a bar to filter.
Top countries
Country of the addressed facility. Click a bar to filter.
Share sent outside the US, by year
Of each year's letters, how many went to a facility in another country. Click a year to filter.
Warning letters by quarter
Issue date of the letter. The latest quarter is partial. Click a column to filter to that year.
Monthly cadence
Letters issued per month. Brighter is busier.
Close-out rate by year
Share of letters with a published close-out letter. Recent years are still open. Click a year to filter.
Inspection to letter
Days from the end of the inspection to the date on the letter. Each dot is a letter; the tick is the median. Only letters that state both dates.
Letter to close-out
Days from the letter to the published close-out, for the letters that have one. Recent years are censored: most are still open.
Issuing center
Each letter counts under the FDA office that sent it; field inspection divisions roll up to the Office of Inspections and Investigations. A few come from FDA's food programs, when the products were drugs, devices or biologics.
Theme
Derived from FDA's subject line. A letter can carry more than one.
How letters route
Product family, to the center that issued the letter, to the primary theme. Ribbon width is letters.
Letter length by center
Median words. Longer letters carry more findings.
Findings per letter
How many stated findings a letter carries, by product family.
How much is withheld
Median (b)(4) redactions per 1,000 words, by issuing center.
Who keeps coming back
Each letter is a dot on its date. Click a dot to open the letter.
The letters, as a table
Every letter in the current filter with sortable columns. Click a row to open it in the panel.
| Letter posted date | Letter issue date | Company | Product | Issuing center | Themes | Cited sections | Findings | Status |
|---|