FDA Issues Interim Final Rule on Record Access Requirements for Food Firms

The Department of Health and Human Services, Food and Drug Administration (FDA), released an Interim Final Rule titled “Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements” which was made effective on March 1, 2012.  This rule expands the FDA’s ability to request access to records about food and articles of food that the Secretary of Health and Human Services believes to have a reasonable probability that the use or exposure to the food could cause serious adverse health consequences or death to humans or animals.  Businesses that manufacture, process, pack, distribute, receive, hold, or import the suspected food would have 24-hours or less to provide data regarding specific food items, including where they came from and where they might have gone after leaving a facility.  The Centers for Disease Control and Prevention (CDC) indicate that approximately 48 million people get sick, 128,000 are hospitalized, and 3,000 die from food borne diseases.  This interim final rule will reduce the impact for food borne diseases when suspected foods are identified earlier, reducing public exposure and additional illnesses. 

The food and beverage industry is no stranger to tracking incoming and outgoing food products, but this new rule does suggest that manufacturers, processers, distributors, and others in the supply chain should tighten up data collection and reporting processes in the event that the CDC begins to investigate a specific food suspected of causing illness.  Appolis, Inc. offers WithoutWire Warehouse, a powerful software built on a Microsoft platform that will provide added visibility and control over inventory and that will meet demanding compliance requirements.  Using data in Advanced Ship Notice or Purchase Orders for incoming products, products are quickly bar-coded upon receipt and moved from the dock to stock faster, saving valuable time for products with short shelf lives.  For the outgoing products, WithoutWire Warehouse uses container/order splitting so that products are picked and shipped out to customers, with greater accuracy and using less labor.  This software will optimize inventory tracking and data collection that will enable you to meet compliance requirements.

The reporting features in WithoutWire Warehouse will provide real-time and historical audit trails for your inventory, as well as enable you to measure performance metrics.  Using any of the 50 built-in report formats or customizing your own, you can determine the status of orders and inventory and easily share data with customers or regulatory agencies.

The regulatory requirements for food and beverage companies can present a challenge to companies without the right software to automate data collection and product tracking.  Contact Appolis, Inc. for details regarding the WithoutWire Warehouse software and how it can help you be ready in case the CDC comes knocking on your door.

By Steve Dwyer of Appolis, Warehouse Management System (WMS) Provider