How to Effectively Meet FDA Reporting Requirements During a Recall

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One of the most recognizable government agencies is the Food and Drug Administration (FDA), which is responsible for protecting public health by monitoring the production and distribution of many product categories, including various foods, drugs, vaccines, medical devices, and cosmetics.

Companies who manufacture goods in these categories must adhere to strict policies enforced by the FDA to ensure that their products meet a certain level of quality, safety, and efficacy. It even goes so far as to monitor certain advertisements and promotional materials for potential violations.

This begs the question: How can a company in one of these industries ensure they are being compliant?

We might be a little biased here at Deacom, but we believe that compliance begins with using a proper ERP system. Our customers’ employees involved in compliance must have a deep understanding of what their industry-specific regulations are, while easily managing and reporting on new and evolving product design, purchasing, production, sales, and quality control. Along with these major business components, the ideal software also supports the functions of labeling and packaging, all facets of inventory management, distribution, and electronic record and signature storage.

With all its functions built on a single software platform and operating on the same data set, DEACOM ERP allows users from all levels of the supply chain to perform their job functions without delay or guesswork. Our software is designed to be implemented within a wide range of customer sites in both regulated and non-regulated industries and allows our customers to efficiently and confidently purchase, produce, sell, and report on operations.

One of the biggest concerns in any FDA-regulated industry is how to properly and easily perform a recall in the event of a contaminated or defective product. To support this need, and conform to the FDA’s identification and traceability regulations, DEACOM utilizes lot tracking, asset tracking, and serialization to allow users to identify and trace material during all stages of handling.

The ERP system also uses the concept of master lots, which are used to group individual lots together, to facilitate moving large quantities of items in one transaction. After a master lot is created, transactions such as inventory moves can be done on the master lot and all the associated lots tied to the master lot will be moved at once. The classic example of a master lot is a pallet of dissimilar items that are grouped together for storage or sales purposes, making inventory movements easier.

The major component of a recall is the ability to quickly generate reports to determine where the contaminated or defective lot came from and where the lot was used. DEACOM’s robust reporting capabilities allow users to filter by facility, customer, specific lots, or “wide open” to view all results. Multiple reports used to track lots and master lots are available from the Inventory Management section of the software.

At the base level are lot reports, which show the quantity and value of each system or master lot in inventory. Additionally, DEACOM offers “Lot Tracking Explosion” and “Lot Tracking Implosion” reports, which provide the user with information regarding where a lot came from and where a lot was used, respectively.

These reports allow the user to determine current lot locations, quantities, and affected orders and customers. In the event of a product recall, a best practice is to utilize these reports to contact all affected lot recipients. This contact is made extremely easy (as easy as a single button click) using the CRM section of the software, which stores address, email, and other contact information for customers.

These tools and many more are available for manufacturers and distributors to ensure they comply with FDA and other agency regulations, all while increasing production speed, maximizing warehouse efficiency, and performing sales on-the-go.

Contact us today to learn more about how DEACOM helps manufacturers strengthen their operations and comply with FDA regulations.

About the author

Domenick Naccarato has been a featured writer on the Deacom blog for the past four years sharing his insight into manufacturing best practice techniques, conversations with customers, and videos of DEACOM experts and users. He has been made famous for his all-too-realistic portrayals of 3rd Shift Harry – yes, that is his mug shot in the photos but he is much less intimidating in person!