Batch Recall Tracker (FDA Compliance)

Product recalls are among the most expensive operational failures in regulated industries. A single contaminated batch of pharmaceutical tablets can force a manufacturer to identify and retrieve distributed units across hundreds of customers in days. A food safety incident in a single production run may require tracing backward through raw material lots and forward through retail channels to consumers. When a recall is initiated, the clock starts: FDA requires that traceability records be provided within 24 hours of a recall request; manufacturers must establish traceability within 24 hours to identify affected batches; communication to customers and regulatory agencies must begin immediately; and all affected product must be quarantined, retrieved, or destroyed within days. Failure to meet these timelines results in regulatory penalties, customer product liability claims, and irreversible reputational damage.

The recall traceability problem manifests across multiple critical dimensions. First, batch genealogy: most manufacturers capture forward traceability (which products consumed which raw materials) poorly or not at all. A production batch contains material from 15 different supplier lots, but the genealogy is scattered across multiple systems—purchasing records, receiving documentation, production logs, and warehouse inventory systems. When a defect is discovered in a finished product, reconstructing which raw material lots were used requires manual cross-referencing and can take days. Second, backward traceability: when a finished product reaches the market, identifying which customers received which batches requires tracing through distribution channels. A pharmaceutical wholesaler may have received batch 2024-0847 but distributed it to 47 different pharmacies under different packaging configurations. Identifying every retail location where the product is available requires manual query of distributor systems, pharmacy records, and customer manifests. Third, recall speed: assembling a complete recall scope requires consolidating data from multiple systems with no real-time integration. Quality teams prepare a recall brief based on available information; supply chain teams query distribution records; regulatory teams coordinate with regulatory agencies; operations teams begin destruction procedures. By the time the recall scope is finalized, 24-48 hours have elapsed during which affected product remains on shelves and in patient medicine cabinets.

The regulatory and business consequences are catastrophic. In 2024, a pharmaceutical manufacturer discovered a microbial contamination in a single production batch. Because batch genealogy was not maintained, the manufacturer could not definitively identify which finished products were affected and had to recall an entire product line—multiple batches manufactured across a 30-day period—destroying $47 million in product. An FDA 483 observation stated "Adequate traceability system not in place." A food manufacturer discovered allergen cross-contamination in a single production run but could only identify that affected product was distributed to a region covering 4 million people. The recall required notification through multiple distribution channels, retail outlets, and direct-to-consumer websites. Post-recall investigation determined the company had no systematic record of which retail locations received affected batches—recall notices were published in newspapers and on the company website, and customers were told to "check the batch number on packaging." A medical device company recalled an implantable device after post-market failures were detected, but forward traceability was so poor that the company could not identify which patients had received potentially defective units. The company had to conduct a blanket communication to all surgeons and hospital systems, triggering patient anxiety and unnecessary revision surgeries. Litigation costs exceeded $12 million.

The root cause is fragmentation across supply chain systems with no integrated traceability. Batch genealogy is not captured during production—the system records "used 500 units of Component A" without recording which supplier lot of Component A. Forward traceability relies on sales order matching rather than actual product allocation. When Wholesaler X orders 1,000 units of Product Y manufactured in Batch 2024-0847, the system records the shipment but not that those exact 1,000 units came from Batch 2024-0847; if Product Y is manufactured continuously, the system cannot distinguish between units from different batches. Backward traceability is even worse—distributors and retailers rarely capture batch numbers in their inventory systems, so when a recall is initiated, customers must manually search their shelves to find affected batch numbers. The missing link is real-time, granular batch genealogy capture and queryable, real-time trace-back capability that can answer "I have batch 2024-0847 of Product Y; show me every customer who received units from this batch" within seconds, not days.

All solutions run on the IoTReady Operations Traceability Platform (OTP), designed to handle millions of data points per day with sub-second querying. The platform combines an integrated OLTP + OLAP database architecture for real-time transaction processing and powerful analytics.

Deployment options include on-premise installation, deployment on your cloud (AWS, Azure, GCP), or fully managed IoTReady-hosted solutions. All deployment models include identical enterprise features.

OTP includes built-in backup and restore, AI-powered assistance for data analysis and anomaly detection, integrated business intelligence dashboards, and spreadsheet-style data exploration. Role-based access control ensures appropriate information visibility across your organization.