FDA Compliance Audit Assistant
Audit FDA FSMA and HACCP compliance to identify gaps before regulatory inspections
What You Can Do
Conduct comprehensive internal audits aligned with FDA FSMA requirements and HACCP principles across seven critical compliance domains. You'll identify and document compliance gaps in facility operations, documentation, personnel training, and supplier controls—mirroring the structure and rigor of actual FDA inspections. Generate detailed findings reports with remediation priorities and defensible corrective action plans that demonstrate systematic controls to FDA investigators.
Features
Example Output
Audit Finding Summary:
Finding #1 (Critical): Inadequate supplier verification documentation for high-risk raw materials
- Regulatory Requirement: FSMA §117.80(b) — Supplier verification program
- Current State: Supplier letters on file; no documented food safety audit records
- Remediation: Implement supplier food safety questionnaire and schedule on-site audits for top 5 suppliers by volume
- Timeline: 60 days
- Verification: Updated supplier files with completed questionnaires and audit reports
Finding #2 (Major): Personnel training documentation lacks content specificity for allergen controls
- Regulatory Requirement: FSMA §117.80(b)(1) — Supervisory personnel training on food safety preventive measures
- Current State: Generic food safety training records; no allergen-specific competency verification
- Remediation: Develop allergen control training module; retrain personnel; document comprehension assessment
- Timeline: 45 days
- Verification: Training roster with dates, topics, and test scores ≥80%
What's Included
- SKILL.md: Complete skill configuration and usage guidelines
- FDA Compliance Audit Checklist: Seven-domain structured evaluation framework with 60+ specific compliance questions
- Findings Documentation Template: Standardized format for recording findings with severity levels, regulatory citations, and remediation details
- Corrective Action Plan Template: CAPA structure with root cause analysis, remediation steps, timelines, responsible parties, and verification methods
- HACCP Verification Worksheet: Point-by-point checklist for validating HACCP plan components (hazard analysis, CCPs, critical limits, monitoring, corrective actions)
Who It's For
- Food Safety Managers and Directors preparing facilities for FDA inspections
- Quality Assurance Leaders conducting routine internal compliance audits
- Operations Managers implementing FSMA and HACCP compliance programs
- Facility Compliance Officers responding to FDA observations or Warning Letters
- Food Safety Consultants supporting client audits and remediation planning
Best For
- Pre-inspection readiness assessments before scheduled or anticipated FDA visits
- Systematic identification of compliance gaps across facilities, suppliers, and documentation
- Root cause analysis and corrective action planning for food safety incidents or recalls
- Quarterly or semi-annual internal audit cycles to maintain compliance evidence
- Training and validation of food safety team understanding of regulatory requirements
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