zook4/fda-cgmp-enforcement-eval

FDA cGMP Regulatory Violation & Audit Dataset (21 CFR)

Instruction-tuning and evaluation pairs built from FDA Warning Letters. Each record links a documented regulatory failure, quoted verbatim from the letter, to its exact 21 CFR citation, a remediation plan, and a ready-to-use instruction/completion pair.

Task

Domain-specific instruction tuning and evaluation benchmark for compliance and legal AI: identifying what constitutes non-compliance under a specific regulation, citing it correctly, and stating the required remediation.

Dataset structure

Records are JSON Lines, one violation per line. All fields are strings.

Field	Description
cfr_code	Statutory citation for the failure, always in the form 21 CFR <part>.<section>[(sub)], e.g. 21 CFR 211.22 or 21 CFR 820.100(a). Citations appear in the source letter.
violation_type	Short category of the failure, e.g. CAPA, Process Validation, Sanitation, Documentation. Free-form, assigned by the generating model.
severity_rating	One of Critical, High, Advisory. Model-assigned judgment, not an FDA classification.
raw_observation	Verbatim snippet from the FDA letter supporting the violation.
corrective_action_plan	Standard procedure and steps required to remediate the failure.
synthetic_instruction	Instruction prompt for fine-tuning, framed around the documented failure. Names the company and the CFR code and adds no facts the letter does not state.
ideal_completion	Structured response that fulfils the instruction.
source_url	URL of the FDA Warning Letter the record was extracted from.
company	Company named in the letter.
issue_date	Letter issue date (MM/DD/YYYY).

FDA redaction markers such as (b)(4) and (b)(6) are replaced with [redacted].

Examples

{
  "cfr_code": "21 CFR 211.192",
  "violation_type": "Failure to Investigate Discrepancies",
  "severity_rating": "Critical",
  "raw_observation": "Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).",
  "corrective_action_plan": "Establish and implement written procedures for thoroughly investigating any unexplained discrepancy or failure of a batch or any of its components to meet specifications, whether or not the batch has already been distributed. Ensure investigations extend to all potentially affected batches and include root cause analysis, corrective and preventive actions, and documentation of conclusions.",
  "synthetic_instruction": "An FDA inspection revealed that Bentley Laboratories LLC failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed, in violation of 21 CFR 211.192. What constitutes non-compliance in this observation, and what specific remediation is required under the regulation?",
  "ideal_completion": "Non-compliance under 21 CFR 211.192 occurs when a firm does not thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, regardless of whether the batch has already been distributed. The regulation requires a thorough investigation, extending to all potentially affected batches, with documented conclusions and appropriate corrective actions. To remediate, Bentley Laboratories LLC must establish and implement written procedures that ensure every such discrepancy or failure is thoroughly investigated, root causes are identified, corrective and preventive actions are taken, and the investigation and its conclusions are fully documented.",
  "source_url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bentley-laboratories-llc-732028-09172026",
  "company": "Bentley Laboratories LLC",
  "issue_date": "09/17/2026"
}

{
  "cfr_code": "21 CFR 120.8(a)",
  "violation_type": "HACCP Plan",
  "severity_rating": "Critical",
  "raw_observation": "Further, you must have and implement a written HACCP plan whenever a hazard analysis reveals one or more food hazards that are reasonably likely to occur during processing, as required by 21 CFR 120.8(a).",
  "corrective_action_plan": "Have and implement a written HACCP plan for the juice products whenever the hazard analysis reveals one or more food hazards that are reasonably likely to occur during processing. The plan must identify control measures and critical control points for the hazards identified in the hazard analysis, including biological hazards from environmental contamination during non-aseptic blending and filling operations, biological hazards from pathogen growth due to time/temperature abuse during processing, and physical hazards (glass fragments) from glass bottling.",
  "synthetic_instruction": "An FDA inspection revealed that Wellmill, LLC dba Vitamix Laboratories did not have and implement a written HACCP plan under 21 CFR 120.8(a). What constitutes non-compliance in this observation, and what specific remediation is required under the regulation?",
  "ideal_completion": "Non-compliance under 21 CFR 120.8(a) occurs when a juice processor fails to have and implement a written HACCP plan whenever a hazard analysis reveals one or more food hazards that are reasonably likely to occur during processing. In this observation, Wellmill, LLC dba Vitamix Laboratories did not have a HACCP plan appropriate for the juice products. The firm's hazard analysis concluded that no food hazards are reasonably likely to occur, but it did not adequately address biological hazards from environmental contamination during non-aseptic blending and filling operations, biological hazards from pathogen growth due to time/temperature abuse during processing, and physical hazards (glass fragments) as product is bottled in glass containers. Because these hazards are reasonably likely to occur, the firm must have and implement a written HACCP plan. To remediate, the firm must develop and implement a written HACCP plan that identifies control measures and critical control points for the hazards identified in the hazard analysis, including the specific biological and physical hazards noted.",
  "source_url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wellmill-llc-dba-vitamix-laboratories-725655-04202026",
  "company": "Wellmill, LLC dba Vitamix Laboratories",
  "issue_date": "04/20/2026"
}

Creation process

1. Collection: FDA Warning Letters were scraped from the public FDA Warning Letters listing (the 30 most recently posted letters at collection time, September 2026) and their body text was extracted.
2. Extraction: a language model (deepseek-chat) acted as a regulatory compliance auditor and extracted each distinct failure with its CFR citation, using a strictly validated schema. Pairs with malformed or non-section-level citations were dropped. Letters that cite only FD&C Act sections, with no 21 CFR section, yield no records.
3. Grounding checks: instructions are framed around the documented failure rather than invented scenarios. In the full edition, every raw_observation is a verbatim substring of its source letter (after redaction normalization), and its cited CFR section number appears in that letter; pairs failing either check were dropped.

Contents

	Open preview (this repo)	Commercial edition
Records	15 curated samples	95 pairs
Source letters	8	21

Commercial edition composition: 55 Critical and 40 High records, with no Advisory labels; most citations fall under 21 CFR Part 211 (drug cGMP), Part 1 (import / FSVP), Parts 117 and 111 (food and dietary supplement cGMP) and Part 120 (juice HACCP).

Limitations

• Synthetic content. corrective_action_plan, synthetic_instruction and ideal_completion are LLM-generated and have not been reviewed by a regulatory professional. Verify before relying on them.
• Not legal or regulatory advice. Do not use as a substitute for qualified counsel or a compliance audit.
• Small and recent. Letters are from a single collection window (2025-2026) and cover a narrow slice of industries.
• Subjective labels. severity_rating and violation_type are model judgments, not FDA designations.
• Redactions. Some snippets contain [redacted] where the FDA withheld information.

Source and attribution

Source documents are public FDA Warning Letters published at fda.gov. The generated fields were produced by a language model; the dataset is not affiliated with or endorsed by the U.S. Food and Drug Administration.

Evaluation Benchmark & Extended Corpus Licensing

The 15-record preview in data/sample_preview.jsonl is provided under the CDLA-Permissive-2.0 license for technical evaluation and integration prototyping.

The complete baseline evaluation corpus contains 95 verified, deterministic instruction-response pairs across 21 FDA Warning Letters (2025–2026), structured for statutory alignment evals, RAG pipelines, and deterministic guardrail validation in life-sciences compliance.

• Baseline Evaluation Corpus (95 Verified Pairs): $299 (perpetual commercial buyout).
• Custom Historical Expansion (Multi-Year 2018–2026 Ingestion): Inquire for tailored multi-thousand-record pipelines.
• Delivery: Immediate access to full .jsonl files and SHA-256 integrity checksums.
• Inquiries & Purchase: Contact bzucker4@gmail.com or request an invoice via Direct Inquiry / PO Request.