warning-letter
fda-warning-letters
FDA Warning Letters, 2018–2026
This dataset contains 6,428 FDA Warning Letters issued from January 2018 through August 10, 2026.
Each record includes the stored FDA source text, canonical FDA URL, source hash, selected metadata, normalized citations, and applicable facility data. The corpus reconciles to the FDA sitemap with a gap of zero for the target period.
The dataset does not interpret violations. It does not give compliance advice. Always verify the canonical FDA source.… See the full description on the dataset page: https://huggingface.co/datasets/tim-a-wood/fda-warning-letters.fda-warning-letterslegal-advice-letter-fact-law-risk-warning-coherence-v0.1What this dataset does
You receive
objective
facts
evidence
legal position
risk warning
assumptions
next steps
file flags
You decide
coherent
or
incoherent
Daily use
advice QC
missing risk warning detection
fact gap detection
contradiction detection
fda-warning-letters
FDA Warning Letters (1,725 enforcement letters across drugs, devices, food, tobacco)
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… See the full description on the dataset page: https://huggingface.co/datasets/emperor-mew/fda-warning-letters.fda-warning-letter-escalation
FDA Warning Letter Escalation Dataset
Version: 1.0.0 | Records: 14,810 | Price: $2,000 | Source: FDA (public domain)
Dataset Summary
The dataset's core signal — whether an inspection escalated to a Warning Letter — is validated against FDA's own severity classifications: OAI inspections escalate at 64% versus 1.7% for NAI, a 39× relationship that confirms the data reflects real regulatory behavior.
The 14,810 inspections that escalated to enforcement — every… See the full description on the dataset page: https://huggingface.co/datasets/RubyIntelligence/fda-warning-letter-escalation.