Cognitio Labs

https://cognitioiq.com

Automating FDA-grade Traceability Requirements with Sensors and AI.

Cognitio Labs is an applied AI research lab building real-time compliance infrastructure for regulated supply chains, serving as the first line of defense against recalls and regulatory failure. When a food contamination event happens, time is everything. Today, traceability relies on spreadsheets, PDFs, and manual logs, turning recalls into multi-day investigations. Entire product categories get destroyed, brands lose trust, and a single recall can cost $10M to $100M+. Why now: The FDA’s FSMA 204 rule requires companies to produce standardized digital traceability records within 24 hours by 2028, impacting over 60,000 U.S. food facilities. The regulatory bar is rising, but the infrastructure to meet it does not exist. Our first product line uses sensors and AI to automatically capture key events such as temperature, handling, and lot-level movements across production, storage, and transit. We convert fragmented operational data into standardized, FSMA 204-compliant traceability records in real time. Compliance is generated as operations happen, not after. This becomes the first line of defense by enabling faster recalls, reducing spoilage, eliminating manual compliance work, and protecting contracts, insurance, and brand equity. We are starting with food and expanding into other regulated, high-risk supply chains.