In the case of a vertically integrated company, does a warehouse owned by the manufacturer need to record lot codes? What are the potential consequences of noncompliance with the rule?
As with other violations of the Food, Drug, and Cosmetic Act, failure to establish or maintain records properly or failure to make records available to FDA when demanded is a "prohibited act. As a practical matter, FDA's ability to monitor compliance is limited.
The agency does not seem to have authority to demand access to records during a routine inspection, for the purpose of confirming that the proper records exist. Rather, FDA can demand access to records only upon a reasonable belief that a food is adulterated and presents a threat of serious adverse health consequences or death. Hopefully, FDA will not often find itself in a position to demand access to records. However, the food industry should take its obligations under the recordkeeping rule very seriously.
While warning letters involving minor questions of interpretation do not seem likely, failure to produce the required records during an emergency will likely result in adverse publicity at a minimum, a public health crisis and criminal prosecution at worst.
David Joy is a partner at the Washington, D. Comments RSS. You are commenting using your WordPress. You are commenting using your Google account. You are commenting using your Twitter account.
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More than that, continues Rastle, it helps maintain quality, which is a growing concern in a global environment. Good tracking and tracing can help ensure that. Why does this batch taste different? What happened? What temperature was used? How long was it cooked, baked, or blended? Capturing those kinds of data can yield better product, and probably lower costs, as well as compliance. But physical security and safety are closely related issues, Guhr insists, and recommends manufacturers perform a security assessment at least annually.
Many plants, she notes, find such an assessment uncovers unexpected points of vulnerability. Data are critical to Bioterrorism Act compliance. How well are your data backed up? Nothing matters without good data from the plant floor. The trend is to install information management systems—for compliance and more. Automation and data collection systems today are far superior to those available even a few years ago. Then, data are collected in the same way, every time.
It needs to be deployed in a way that will work for your operation. And making it work is what is critical. Voluntary cooperation. Instant enforcement. An incident occurs and the government immediately finds a way to enforce the law and impose penalties. Laws acquire teeth. Fast discovery is especially significant in the case of dairy and food products manufactured in environments where lots are mixed and byproducts created and reused or sold to other manufacturers.
One of the most important things the FDA wants to see when conducting an investigation is that the manufacturer can accurately include all products that could have been adulterated by the incident. Residual product left in a tank, silo, or processing equipment between qualified, full washes or CIP clean-in-place operations;. Residual product that could have been left in pipes or valves, even in minor amounts, between qualified, full washes on that CIP circuit;.
Residual product left in a transport container, including tanker trucks, totes, and bins;. Any points of possible contamination, such as caused by cross connections of pipes, overflows, pressure relief valves, or bypasses. Manufacturers can do this simply by including all products that could have been in storage and processing during the suspected time frame of the adulteration. It is equally important for a manufacturer to be able to exclude all products that could not have been adulterated.
This effort should consist of:. Bulk dry or liquid materials added to a storage tank or silo after a downstream destination has changed;. Because their products already met Quality Assurance International organic standards, recent FDA traceability requirements were nothing new to the Quinoa Corporation. WiSys grid reports like purchase-to-lot, production-to-lot, invoice-to-lot and shipment-to-lot show the lot control information required by the FDA and can be exported to Excel and printed quickly and easily.
Implementing a food safety and traceability program should satisfy government and industry compliance requirements as well as provide you with better visibility and control while minimizing risks to your customers and company. Close Search.
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