FLEET MANAGERS

FSMA Compliance Checklist

Published on August 16, 2025 by Joe Shayovitch

Contents

1 Introduction

What is FSMA?

The Food Safety Modernization Act (FSMA), signed into law in 2011 by the U.S. FDA, is the most sweeping reform of food safety laws in over 70 years. Unlike reactive policies of the past, FSMA emphasizes preventive and risk-based controls to ensure the U.S. food supply is safe from contamination, both accidental and intentional.

Why is FSMA Compliance Critical?

Non-compliance with FSMA can result in severe consequences:

FDA inspections and shutdowns
Costly product recalls
Civil or criminal penalties
Loss of market access for foreign suppliers

Use this comprehensive FSMA compliance checklist to meet FDA standards, pass inspections, and ensure consumer safety.

FSMA Compliance Checklist

This checklist is organized based on the 7 foundational FSMA rules, as outlined by the FDA, plus key supporting elements.

1. Preventive Controls for Human & Animal Food

Key Regulations: 21 CFR 117 Subpart C (Human), Subpart B (Animal)

Hazard Analysis
Identify biological, chemical, physical, and radiological hazards across supply chain stages.
Preventive Controls
Implement:
- Process controls (temperature, pH, etc.)
- Allergen controls
- Sanitation procedures
- Supply-chain controls
Monitoring Procedures
Set measurable standards and tools (e.g., temperature logs).
Corrective Actions
Establish immediate steps for deviations (e.g., re-inspection, re-training).
Verification Activities
Include internal audits, calibration checks, and validation tests.
Record-Keeping
Maintain detailed records for every control step, as per 21 CFR 117.305.

2. Produce Safety

Key Regulations: Produce Safety Rule (21 CFR 112)

Agricultural Water Testing
Biological Soil Amendments control
Employee Hygiene & Training programs
Domesticated and Wild Animals management
Sanitary Equipment usage
Traceability of produce through all stages

3. Foreign Supplier Verification Program (FSVP)

Applies to: U.S. importers of food

Supplier Risk Assessment
Onsite Audits & Sampling
Documented Approvals
Ongoing Monitoring
Records retention (2+ years)

4. Sanitary Transportation

Key Rule: 21 CFR 1 Subpart O

Cleanliness of vehicles & equipment
Temperature control measures
Employee training for loaders and transporters
Contamination prevention from previous loads
Record maintenance for at least 12 months

5. Accredited Third-Party Certification

Verify auditors are FDA-accredited
Use consultative audits for suppliers
Ensure regulatory audits meet FSMA criteria
Maintain audit reports for verification

6. Food Traceability

Updated by: FDA Traceability Rule (2022)

Track-and-trace systems for high-risk foods (e.g., leafy greens, cheeses)
Key Data Elements (KDEs) logged per Critical Tracking Event
Rapid recall protocols must be ready
Full traceability from source to consumer

7. Prevention of Intentional Adulteration

Required for: Facilities >$10M revenue or >500 employees

Vulnerability Assessments
Mitigation Strategies (e.g., controlled access, surveillance)
Food Defense Plan
Staff Training
Monitoring & Records

Supporting Components of FSMA Compliance

These are not separate rules but integral to all FSMA-covered facilities:

Food Safety Plan
Core document outlining all preventive controls, developed by a Preventive Controls Qualified Individual (PCQI).
Allergen Management
Controls for storage, labeling, and segregation of allergenic ingredients.
Recall Plan
Procedures for identifying, notifying, and retrieving unsafe products.
CGMP Compliance
Adherence to Current Good Manufacturing Practices (21 CFR 117 Subpart B), including:
- Personal hygiene
- Pest control
- Facility maintenance

FSMA Documentation Checklist (Quick Reference)

Requirement	Required Document
Hazard Analysis	Hazard Identification Report
Preventive Controls	Food Safety Plan
Monitoring	Log Sheets
Corrective Action	Incident Reports
Verification	Internal Audit Logs
Allergen Control	Ingredient Inventory
FSVP	Supplier Approvals & Certifications
Sanitary Transport	Vehicle Inspection Logs
Traceability	KDE Tracking Sheets
Intentional Adulteration	Food Defense Plan

Downloadable FSMA Checklist Template (PDF)

Want a printable version for your facility?
Download Your Free FSMA Compliance Checklist PDF

Additional FSMA Resources

FDA FSMA Final Rules Overview
PCQI Training Providers (FDA-Recognized)
Guidance Documents for Industry

Final Thoughts

FSMA compliance isn’t a one-time task,it’s a continuous commitment to food safety. With robust systems, well-trained staff, and thorough documentation, your facility can meet FDA expectations, build trust with customers, and protect public health.

Stay ahead of audits and reduce your risk by making this checklist part of your daily operations.