FDA FSMA 21 CFR Part 117 Recall Procedures Readiness Checklist
This checklist covers FDA FSMA 21 CFR Part 117 Recall Procedures Readiness Checklist requirements under applicable federal and industry regulations. Violations may result in civil penalties up to $15,625 per violation per day and potential operational suspension.
- Industry: Food & Hospitality
- Frequency: Annual
- Estimated Time: 20-30 minutes
- Role: Quality Director
- Total Items: 20
- Compliance: 21 CFR Part 117, FSMA 2011, CODEX HACCP
Regulatory Documentation & Compliance Status
Verify current regulatory compliance status and required documentation is in order.
- Is the written food safety plan current, complete, and signed by a qualified individual?
- Are all critical control points monitored at required frequencies with records maintained?
- Are corrective actions documented for any CCP critical limit deviations?
- Attach photo of HACCP monitoring records and temperature logs:
Temperature Control & Environmental Monitoring
Verify food safety temperature controls and environmental monitoring.
- Are temperature-controlled storage areas maintained within required temperature ranges?
- Are environmental monitoring samples collected per the written EM program?
- Refrigeration unit temperature reading (degrees F):
- Attach photo of temperature monitoring logs and cold storage:
Work Practices & Housekeeping
Evaluate worker compliance with safe work practices and housekeeping standards.
- Are workers following established safe work procedures and using required PPE?
- Is housekeeping adequate with no trip hazards, blocked egress, or unsecured materials?
- Work area safety and housekeeping assessment:
- Attach photo of work area conditions and housekeeping:
Previous Findings Review & Supervisor Certification
Review prior findings and obtain supervisor acknowledgment of current inspection.
- Have all findings from previous inspections been corrected and verified effective?
- Is supervision aware of all current compliance issues and engaged in resolution?
- Total corrective actions assigned from this inspection:
- Responsible supervisor or area lead certification of inspection:
Corrective Actions & Inspector Sign-Off
Document all deficiencies and assign corrective actions. POPProbe auto-assigns these to team members, generates a signed PDF report instantly, and tracks compliance status across all locations. -> Start free, no credit card required
- List all deficiencies identified in this inspection:
- Overall compliance status?
- Corrective actions assigned to (name and department):
- Inspector digital signature and date:
Related Food & Hospitality Checklists
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- HACCP Plan - Principles 4-5 Monitoring & Corrective Action
- HACCP Plan - Principles 6-7 Verification & Record Keeping Audit
- FSSC 22000 Version 6 Food Safety Management System Audit
- USDA FSIS HACCP Verification for Meat & Poultry Processing
- USDA FSIS Sanitation Standard Operating Procedures SSOP Checklist
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Why Use This FDA FSMA 21 CFR Part 117 Recall Procedures Readiness Checklist?
This fda fsma 21 cfr part 117 recall procedures readiness checklist helps food & hospitality teams maintain compliance and operational excellence. Designed for quality director professionals, this checklist covers 20 critical inspection points across 5 sections. Recommended frequency: annual.
Ensures compliance with 21 CFR Part 117, FSMA 2011, CODEX HACCP. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the FDA FSMA 21 CFR Part 117 Recall Procedures Readiness Checklist cover?
This checklist covers 20 inspection items across 5 sections: Regulatory Documentation & Compliance Status, Temperature Control & Environmental Monitoring, Work Practices & Housekeeping, Previous Findings Review & Supervisor Certification, Corrective Actions & Inspector Sign-Off. It is designed for food & hospitality operations and compliance.
How often should this checklist be completed?
This checklist should be completed annual. Each completion takes approximately 20-30 minutes.
Who should use this FDA FSMA 21 CFR Part 117 Recall Procedures Readiness Checklist?
This checklist is designed for Quality Director professionals in the food & hospitality industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.