Ingredient-Component Supplier Qualification
04-13-2010
By Willie Bryant
Some manufacturers regulated by the FDA and USDA have internal controls that satisfy government regulations for their production operations. Occasionally these manufacturers find themselves in the position of having to recall a product due to a defective ingredient or component from a supplier. Although this situation may occur across the five FDA industry centers as well USDA meat processors, one of the most recent events has occurred in the food industry with the spice pepper. It is not always easy to track a food contamination back to a single ingredient. But when it happens, an entire industry may start paying more attention to qualifying its suppliers and addressing recall preparedness.
The pepper issue was identified by USDA, CDC, and published statements by product manufacturers following a voluntarily recall of meat products because of the presence of Salmonella.
The “root cause” investigation identified an imported black pepper used to coat some of the food products as the source of the Salmonella contamination. After further examination, the Department of Health announced that an open container of black pepper used in the processing of the recalled products tested positive for Salmonella. In fact, the DNA fingerprint of the bacteria from the black pepper matched strain associated with a national Salmonella outbreak.
Last year’s large-scale recall of peanuts and peanut products, also due to Salmonella, resulted in many recalls by manufacturers who had used the contaminated peanut products as an ingredient in their products. The medical device industry has faced similar issues with recalls when a component manufacturer or processor changed or failed to meet manufacturing specifications for a component without the knowledge of the final device manufacturer.
The FDA has regulations and guidance documents which detail the type of controls that should be implemented to qualify a supplier of ingredients or components. Likewise the documents outline controls to validate certificates of analysis and similar reported testing or analytical results. As a manufacturer, you should take all the necessary steps to make sure that ingredients and components used in your products meet all regulatory requirements and manufacturing specifications before they are used in product manufacturing. Doing so may prevent a devastating product recall; potential harm to the public, to the brand and firm image; and regulatory or other legal repercussions.
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