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January 2021
Depending on the type of products you intend to register, you may find yourself trying to figure out whether your meat or poultry, egg, or red meat product is regular by the FDA or if it needs to be evaluated by the U.S. Department of Agriculture (USDA).USDA oversees poultry. Poultry is classified as any tamed...
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Most types of food facilities are mandated by the FDA to incorporate plans for Hazard Analysis and Risk-Based Preventive Controls (HARPC). While much of the same areas can be addressed by a Hazard Analysis and Critical Control Points (HACCP) program, there are a few basic variations. In regards to hazard analysis, HARPC plans must take...
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Are you looking to introduce a new cosmetics product? If so, you may need to have it cleared by the Food and Drug Administration (FDA) and there is also the possibility that it may be regulated as a drug. This will depend on whether the cosmetic is aimed at diagnosing, curing, mitigating, treating, or preventing...
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Part of maintaining FDA compliance is ensuring that you’re taking all of the necessary precautions and steps to be compliant in the event of an FDA inspection. Where others have run into violation issues, you can avoid making these same mistakes by being aware of some of the most common violations and employing the steps...
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The Food Safety Modernization Act (FSMA) signed into law back in 2011 allows the FDA to regulate how foods are grown, harvested, and processed. Among its powers, the FDA can issue a recall if necessary. Hence, you must comply with the FSMA and its various rules.Food facilities are mandated by the FDA’s Preventive Controls Rules...
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Before we get to the primary topic, you should know that the United States FDA Registration Renewal period closed on December 31, 2020. If your renewal was not processed by the deadline, you are required to go through the FDA re-registration process. Today, we’d like to briefly talk about the number of FDA Unique Device...
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A labeler is identified by the FDA as any entity that causes a label to be attached to a product to commercially sell the device without any subsequent substitution or alteration of the label.Also…An individual who causes the label of a product to be replaced or altered to sell the device commercially without any resultant...
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