FSMA 204 Is Here. Is Your Cold Chain Ready?

If you're in the business of producing, processing, or transporting temperature-sensitive goods, compliance just got critical. The FDA’s Food Safety Modernization Act (FSMA) Section 204 has officially gone into effect, and with it comes new demands for end-to-end traceability and real-time temperature visibility.

Strategic Systems and Zebra Technologies offer a powerful solution: Zebra’s Electronic Temperature Sensors, designed to bring cold chain visibility up to regulation and beyond.

What Is FSMA Section 204?

Known as the Food Traceability Final Rule, FSMA 204 requires businesses handling certain high-risk foods to maintain a complete digital trail of where their products have been, including:

• When they were received
• How they were stored
• What temperature conditions they were kept in
• When and how they were shipped

Manual logs, spreadsheets, and delayed reporting won’t cut it anymore. The FDA wants real-time, electronic, and auditable records and businesses must act now to remain compliant.

Traditional Cold Chain Monitoring Isn’t Enough

Too many organizations still rely on paper-based logs or disconnected data points, exposing themselves to risks like:

• Spoiled or out-of-spec product
  
• Inaccurate or missing documentation
  
• Costly recalls or rejected shipments
  
• Fines and compliance violations
  

Zebra’s temperature monitoring system turns this reactive process into a proactive, automated strategy.

Zebra’s Electronic Temperature Sensors: Built for FSMA Compliance

Zebra’s Bluetooth-enabled temperature sensors provide continuous monitoring and cloud-based tracking, creating a digital log from supplier to receiver.

Features include:

• Small, reusable sensors attach to pallets, containers, or product shipments
• Continuous temperature and location monitoring
• Automated alerts for any temperature excursions
• Full integration with Zebra’s cloud platform for access anytime, anywhere
• Downloadable, audit-ready reports to meet FSMA 204 requirements

Use Case Scenarios

Food Distribution
Track perishable goods through warehouses and last-mile delivery with real-time visibility.

Pharmaceuticals
Monitor vaccine and medicine shipments under strict cold storage requirements, with built-in alerts if conditions deviate.

Grocery Retail Chains
From central distribution to in-store refrigeration, Zebra sensors help retailers meet FSMA guidelines and ensure product quality.

Why Work with Strategic Systems?

Strategic Systems helps cold chain businesses deploy temperature sensor solutions with ease backed by expert service and seamless onboarding.

We provide:

• FSMA compliance assessments
• Zebra sensor hardware sourcing
• Cloud platform setup and configuration
• Alert workflows, reporting templates, and training
• Long-term tech support and updates

Our end-to-end approach ensures your business isn’t just compliant, it’s optimized.

Get Ahead of FSMA 204

The deadline is here. Are you ready to prove that your cold chain is traceable, accountable, and fully compliant?

With Zebra’s electronic temperature sensors and Strategic Systems’ expertise, you’ll gain complete visibility and peace of mind. Learn more about Zebra’s FSMA 204-ready sensor technology.