Dataset · revision 2026-10-23.1
FDA drug Warning Letters attributed to directory companies, by year and country
FDA drug Warning Letters, 2008–2026, that PharmaTek attributed to a company in its directory, counted by year issued and by the country in the FDA record.
Revision 2026-10-23.1, published 23 Oct 2026, 02:35 UTC · SHA-256 87c455aedc16d195d23a6c060d25b279d8f50a6c4664ee51090011fea7814619
- Population
- 732 drug Warning Letters from the FDA Data Dashboard compliance actions that matched a directory company by exact name, stored on 23 Oct 2026.
- Method
- Letters are kept only when attributable to a directory company, then counted by issue year and by the country in the FDA record.
- Limitations
- Not a census of FDA Warning Letters: unattributed letters are not stored and directory coverage grew over time, so year counts do not measure FDA activity. About 92% of enforcement links point to the right legal entity.
- Licence
- Derived counts under CC BY 4.0 (credit “PharmaTek Intelligence”); FDA records are US public domain.
Columns
| Column | Meaning |
|---|---|
| breakdown | year or country |
| value | The year issued, or the country recorded in the FDA letter record |
| warning_letters | Letters in that year or country |
Query used for this release
select 'year' as breakdown, extract(year from event_date)::int::text as value, count(*) as warning_letters
from core2.regulatory_events where event_type = 'warning_letter' group by 2
union all
select 'country', coalesce(nullif(country, ''), 'Not recorded'), count(*)
from core2.regulatory_events where event_type = 'warning_letter' group by 2
order by 1, 3 desc;Revisions
Every published revision stays downloadable. Cite the revision you used; a later revision supersedes it but does not replace it.
| Revision | Published | Rows | SHA-256 |
|---|---|---|---|
| 2026-10-23.1current | 23 Oct 2026, 02:35 UTC | 58 | 87c455aedc16d195… |
Earlier revisions were published at a dated path that was overwritten when a correction was made; they are restored here from version control, timed by the change that published each one.
Sources
Cite as: PharmaTek Intelligence, “FDA drug Warning Letters attributed to directory companies, by year and country”, revision 2026-10-23.1 (SHA-256 87c455aedc16), https://pharmatek.co.uk/data/fda-warning-letters. See the methodology and corrections.