The FDA FSMA 204 rule requires businesses that manufacture, process, pack, or hold foods on the FDA's Food Traceability List to maintain detailed electronic records to allow for rapid identification and removal of adulterated foods.
Key aspects of this rule include the following:- Food Traceability List (FTL): Specific high-risk foods
- Critical Tracking Events (CTEs): Records of harvesting, cooling, packing, shipping, receiving, etc.
- Key Data Elements (KDEs): Specific information (i.e., lot codes, supply chain)
- 24-hour Rule: Records must be provided to the FDA within 24-hours of request
- Scope: Covers domestic and foreign companies involved with food on the FTL
