Compliance
FSMA Section 204 coverage from day one
Loamy captures every Key Data Element and Critical Tracking Event the FDA requires under Section 204, structured to answer a records request within 24 hours of receipt.
FSMA Section 204
What the rule requires and how Loamy covers it
Key Data Elements
Section 204 defines specific data fields that must be captured at each supply chain event for foods on the Food Traceability List. Loamy extracts KDEs automatically from incoming certificate documents: traceability lot codes, quantities, commodity descriptions, and location identifiers.
Critical Tracking Events
FDA defines six Critical Tracking Events where records must be maintained: Growing, Receiving, Transforming, Creating, Shipping, and Cooling. Loamy captures each CTE type at the corresponding supply chain handoff and stores it as a graph edge with the associated KDEs and certificates attached.
Records Request Response
Under Section 204 enforcement, FDA may request traceability records within 24 hours of a recall action. Loamy produces a complete, structured records package in minutes, covering all KDEs, CTEs, and certificates for the affected lot chain, exportable in FDA-accepted electronic format.
Requirement Mapping
FSMA Section 204 requirements vs. Loamy coverage
| FSMA 204 Requirement | Requirement Detail | Loamy Coverage | Method |
|---|---|---|---|
| Traceability Lot Code | Unique identifier for each lot of a food on the Food Traceability List | Covered | Extracted from certificate documents automatically |
| Location Identifier | Business name and physical address for the location at each CTE | Covered | Parsed from certificate issuer and recipient fields |
| Date of CTE | Date the Critical Tracking Event occurred for each covered food | Covered | Date extracted from shipping and certificate documents |
| Quantity and Unit of Measure | Amount of food and unit (cases, pounds, pallets) at each CTE | Covered | Normalized across certificate layouts to standard schema |
| 24-Hour Records Access | Ability to produce records within 24 hours of an FDA request | Covered | Structured export package generated on-demand in minutes |
Related Regulations
FSIS and USDA traceability requirements
While Loamy is designed primarily around FDA FSMA Section 204, food producers subject to USDA FSIS jurisdiction for meat, poultry, and egg products face related lot-level recordkeeping obligations. Loamy's certificate ingestion and graph architecture can support FSIS record retrieval workflows, though FSIS-specific regulatory configuration is handled case-by-case in enterprise implementations.
For operations that ship products covered by both FDA and USDA authority, contact our team to discuss how Loamy maps to your combined compliance obligations.
FSMA 204 Readiness
Get your operation ready for a records request
Section 204 enforcement is active. Request a pilot scoping call and our compliance team will assess your current certificate workflow against the requirements.