FDA FSMA 204
Food Safety Modernization Act & Recall Readiness
FSMA 204, enacted in January 2023, requires total
traceability to vessels or farms using the same traceability lot codes. Another requirement is being able to produce a sortable electronic spreadsheet within 24 hours.
Starting now to build your traceability plan is essential. You must be ready—public health depends on it.
Trust TR5 for the solution.
FSMA 204 & Recall Readiness
To protect public health
If you don’t comply
- Risk to people’s health and even death
- Lost customer and consumer confidence resulting in lost sales and severe brand damage
- Lawsuits and litigation – criminal and civil
- Higher insurance rates and the potential to lose coverage
- Multi-million-dollar impacts including compliance penalties, and lost sales
TR5 Solutions & Benefits
- Links single lot number throughout
- Easy to create on-demand digital documents
- Sortable electronic spreadsheets and dashboards to monitor FSMA compliance (coming)
- Less public health risk
- Faster, lower volume, lower cost recalls
- Mitigate brand damage
- Proactive compliance with FDA requirements
Planning for FSMA 204
A Trace Register customer in the gulf of Mexico is fishing, buying, and processing wild-caught gulf shrimp (pink/white/brown). They operate as the first receiver, processor, and distributor. They need a solution for their current buyer requirements and a solid plan to address upcoming FDA FMSA 204 rules.
- Currently, they have records in many places and are missing some of the KDEs they will need for FSMA 204.
- They need a working plan to comply with FSMA 204.
- The company doesn’t have a lot of extra bandwidth to do additional record-keeping and needs time-saving solutions while also managing complex regulatory and buyer requirements.
Threats of Not Complying with FSMA 204
- Risk to people’s health & even death
- Time-consuming, high-cost recalls
- Denial of entry into U.S. commerce
- Compliance penalties
- Severe brand damage
- Advisory action letters
- Criminal or civil action in Federal Court
- Lost customer & consumer confidence
- Lost sales
- Lawsuits & litigation
- Higher insurance rates
- Lost insurance coverage
- Multi-million dollar impacts
TR5 Solutions and Benefits
- With TR5, this company can make solid claims about their traceability to current and potential buyers
- TR5 enables them to look for potential threats before they happen proactively
- They can minimize risk and potential threats to the consumer and their brand
The TR5 Difference
- TR5 provides a way for them to build their individual FSMA 204 plan and to gather/store/organize all of the required documentation in the form(s) required by the FDA
- TR5 will allow them to pull all required KDEs and traceability information within minutes in a sortable digital document (coming soon)
- Because TR5 can be used to model any complexities in the supply chain, it can simplify the record-keeping process and provide time-saving efficiency, even as more KDEs are collected
- Better traceability is the result