What a recall is, how FDA classifies it, and what to have in place before one starts.
When a food company discovers that a product on the market could hurt someone, the quality of its response is decided long before the problem appears. This course covers what a recall is, who can start one, and how FDA classifies it. Most food recalls are voluntary, started by the company itself. Under FSMA, though, FDA can order a recall of adulterated food, or food with an undeclared allergen, that is likely to cause serious harm or death if the company does not act. Class I recalls involve a reasonable probability of serious adverse health consequences or death, Class II recalls involve temporary or medically reversible harm, and Class III recalls involve products unlikely to cause adverse health consequences.
Speed matters from the first hour. Under the Reportable Food Registry, a responsible party that determines a food is reportable must submit a report through the FDA Safety Reporting Portal within 24 hours, giving FDA the product and lot details, the nature of the problem, and the immediate sources and recipients of the food. That timeline is only realistic when the facility already has a written recall plan, as Part 117 requires for any hazard requiring a preventive control. The plan must describe how to notify direct consignees, notify the public when appropriate, conduct effectiveness checks, and dispose of recalled food.
None of it works without traceability. The Bioterrorism Act recordkeeping rule requires one-up, one-back records identifying the immediate previous source and immediate subsequent recipient of food, available to FDA within 24 hours of an official request, with lot or code numbers recorded wherever they exist. The FSMA Section 204 Food Traceability Rule adds a second layer for foods on the Food Traceability List, such as leafy greens, fresh-cut produce, shell eggs, soft cheeses, and finfish. It requires key data elements for critical tracking events, linked by traceability lot codes and deliverable to FDA as a sortable spreadsheet within 24 hours. Compliance is required by July 20, 2028, extended from the original January 2026 date.
This course gives your team a practical picture of what to have in place before a recall starts, and what FDA will expect to see when one does.
The quality of a recall response is decided long before the problem appears. A written recall plan and traceability records that can be delivered to FDA within 24 hours are what make a fast, effective response realistic.
Completion certificate, PDF slide download, and access to the complete GMP course library from day one.
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