Registrar Corp’s FDA Compliance Monitor, a supply chain risk management automation tool, is used by nearly a thousand importers daily to monitor their suppliers’ compliance activity and make informed purchasing decisions with predictive analytics tools. Read on to learn the different ways three U.S. Importers are using the FDA Compliance Monitor to save time and money and reduce the risk involved in their compliance and sourcing activities.

The Monitor was built in 2016 with U.S. Food and Drug Administration (FDA) regulations in mind. The FDA Foreign Supplier Verification Program (FSVP) rule requires that U.S. food importers monitor and document their foreign suppliers’ compliance, including identifying any warning letter, import alert, or other FDA compliance action related to food safety. The FDA Compliance Monitor facilitates FSVP compliance by checking suppliers against six FDA databases daily, notifies users when compliance information changes, and archives monthly compliance reports.

After considering several solutions for complying with FSVP requirements, Limson Trading Inc. determined that Registrar Corp’s FDA Compliance Monitor was the perfect solution. “All of the areas we need to monitor are located in one easy to access place, and it’s simple to download the data to a spreadsheet if we needed it,” said Steve Brunsting, Vendor Compliance and Sourcing Manager at Limson Trading Inc. “The implementation of RegiScore improved the product even more.”

In 2020, Registrar Corp introduced a proprietary risk evaluation tool known as RegiScore. RegiScore empowers importers to easily gauge the risk an existing or potential supplier presents based on their compliance and shipment history, similarly to how FDA utilizes PREDICT to make decisions on what products to inspect at U.S. ports of entry.

Mr. Brunsting said Limson was “looking at a great deal of time and money needing to be spent to manually research and track over 150 suppliers in our importing business” before implementing the Monitor.  Use this savings calculator to see how much time and money the Monitor could save you by automating your supplier monitoring efforts.

The latest addition to the FDA Compliance Monitor is the Document Management System (DMS). This tool facilitates compliance with FSVP record keeping and supplier documentation requirements. With this enhancement, users can easily request, evaluate, approve documentation from their suppliers, including Food Safety Plans, labels, inspection reports, and more–all from within one secure system.

“We were very appreciative of learning about the newly available Document Management System (DMS) as a timely solution to an increasingly difficult issue of following up on supplier document submissions as our supplier base grows”, said Frederick Robinson, Director of R&D and Co-pack Quality at Jasper Wyman & Son, a long-time Monitor user.  “A top feature is the ability to link the document system with the existing multi-supplier monitoring.”

Mr. Robinson and his team have begun implementation of the DMS which will replace their internal filling and database management system for supplier follow-ups.

The Monitor has also proved to be an important support for food safety scheme certification audits.

“The FDA Compliance Monitor was invaluable during our SQF Audit,” said Emma Raven, Quality Compliance Manager from Capstone Nutrition. “We were able to display our supply chain and show auditors the level of our due diligence on our suppliers. Auditors were impressed and we passed our audit.”