Every formal FDA Warning Letter the FDA has posted since ~2005 — 1,725 letters issued by the various FDA centers (CDER, CFSAN, CTP, CDRH, CVM, CBER) to companies whose inspections found significant regulatory violations. Each letter is the agency's official 'you must fix this or face enforcement.' Warning Letters are the leading indicator for FDA enforcement — they precede consent decrees, seizures, and injunctions. Pairs with `fda_recalls`, `fda_510k`, and `fda_adverse_events` for the full FDA regulatory picture.
Every record in this dataset can be traced back to its primary source at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters. Underlying content is a US federal government work (public domain under 17 USC §105); our derived data is licensed CC0 1.0.