Each letter comes with the full FDA text, the findings FDA wrote and the regulations it cited. Search by company, regulation, product or date, or read the trends across the whole record.
Three ways in
- 01 · Regulations
Understand a citation
Read the regulations cited in FDA warning letters, then explore the letters that reference them.
Browse regulations - 02 · Letters
See every letter like it
Filter by product, regulation, issue type, place and date. The matching letters sit beside the filters, each open to read.
Browse letters - 03 · Research
Find the pattern
Trends, regulations cited together, locations, timing, issuing centers and repeat recipients across the whole record.
Open Research
Three citation trends to explore
Largest changes in letter counts through Oct 30, 2026, compared with the same dates in 2025. Counts include all citation mentions, one count per letter. References affected by the QMSR transition are excluded from this ranking.
21 CFR 201.1
+51 letters
Explore this trend →21 CFR 201.128
+23 letters
Explore this trend →21 CFR 211.160
+18 letters
Explore this trend →
The latest letters FDA posted
Read one, then open Letters on every letter of the same product type that cites the same regulation.
- DrugsPosted Nov 3, 2026RonanRx, Inc. dba RonanRxSee all 1,351 drug letters
- DrugsPosted Nov 3, 2026Conroe Welding Supply, Inc.See all 1,351 drug letters
- DrugsPosted Nov 3, 2026Guangdong Bisutang Biotechnology Co., Ltd.See all 1,351 drug letters
- DrugsPosted Nov 3, 2026Guangzhou Jiugong Research And Development Biotechnology Co., Ltd.See all 287 drug letters citing 21 CFR 211.22 (292 across all products)
- DrugsPosted Nov 3, 2026Pritam International Private LimitedSee all 267 drug letters citing 21 CFR 211.84 (275 across all products)
- DrugsPosted Nov 3, 2026Bella’s Nutri Shop Inc.See all 321 drug letters citing 21 CFR 201.128
One letter is a data point. 1,703 letters show the pattern.
Questions the whole record answers
- TrendsWhich regulations FDA cites most, and how the counts change.
- RelationshipsWhich sections FDA cites together in the same letter.
- LocationsWhere the addressed facilities are, by country and state.
- TimingWhen letters are issued and posted, and the time between.
- Issuing centersWhich FDA center sent each letter, and on what themes.
- Repeat recipientsCompanies that received more than one letter.
What an FDA warning letter is
A warning letter is FDA’s formal notice that an inspection or a review found violations serious enough to require a written response, usually within 15 business days. For drug makers the findings are mostly cGMP failures under 21 CFR Parts 210 and 211. For device makers they were, until February 2026, failures under 21 CFR Part 820, and are now cited against ISO 13485 under the QMSR. A warning letter is not the inspection report (that is the Form 483) and it is not a penalty. It is the public record of what FDA found and what it expects the company to fix.
Frequently asked questions
- How many FDA warning letters were issued in 2025?
- 406 to drug, medical device and biologics makers. Food, cosmetics, tobacco and veterinary letters are not included in that figure.
- Which regulation is cited most often in FDA warning letters?
- 21 CFR 201.128, cited in 321 letters since 2021.
- What is the difference between a Form 483 and a warning letter?
- A Form 483 lists inspectional observations at the end of an inspection. A warning letter is FDA’s later, formal notice that violations were found and a written response is required.
- Do device warning letters still cite 21 CFR Part 820?
- Letters from inspections that started before February 2, 2026 still do, and will for some time. Letters from inspections after that date cite ISO 13485:2016 clauses and the new sections of Part 820 (820.10, 820.35 and 820.45).
Counts from the Botable FDA Warning Letter Database, 1,703 letters, checked Nov 6, 2026. How this database is built.