Resources · FDA warning letters
Explore FDA warning letters.
Explore 1,653 published letters to drug, device and biologics makers since 2021. Choose your focus, then follow the evidence.
| Product type | Letters |
|---|---|
| Drugs | 1,311 |
| Medical Devices | 259 |
| Biologics | 83 |
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Open analysisThe published record at a glance
| Year issued | Letters |
|---|---|
| 2021 | 262 |
| 2022 | 230 |
| 2023 | 234 |
| 2024 | 246 |
| 2025 | 406 |
| 2026 | 275 |
| Most cited sections and clauses in extracted findings | Letters |
|---|---|
| 21 CFR 211.84 | 246 |
| 21 CFR 211.100 | 203 |
| 21 CFR 211.165 | 164 |
| 21 CFR 211.192 | 151 |
| 21 CFR 211.22 | 125 |
Counts describe this saved dataset, not a company’s current compliance status. Recent letters link to the original FDA source.