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As protective equipment to combat and remain safe from the coronavirus surges, there has been a rise in unauthorized medical equipment and products. The FDA has now revealed its actions against businesses that market devices by falsely claiming approval, certification, permission, or oversight from the agency. Certain businesses may be using something called “FDA registration...
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In an effort to standardize and digitize traceability in the supply chain, the FDA recently proposed a rule. The planned food traceability rule refers to the provision of section 204 of the Food Safety Modernization Act to assign the foods requiring additional record keeping for customer safety and sets out the corresponding criteria. The rule...
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We’ve talked a lot about the various intricacies, laws, and steps involved with FDA registration and making sure everything is done correctly. However, we also wanted to share that all of those can be simplified by using our UReg FDA Registrations portal! Instead of having to deal with lawyers, tons of paperwork, and steps that...
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According to a Food Engineering post, nearly 60,000 food facilities were removed by the FDA last month alone, leading to a decrease of more than twenty percent in the number of facilities with a valid agency registration. Food facilities are expected to renew their FDA registrations for an even-numbered year between the first of October...
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The North American Free Trade Agreement (NAFTA) assists with protecting the Food and Drug Administration (FDA) of the United States’ right to guarantee food safety and consistency within North America. Implemented on January 1, 1994, the agreement involves Canada, the United States, and Mexico and is meant to expand the scope of free trade and...
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Companies that manufacture goods subject to U.S. Food and Drug Administration (FDA) regulation are required to declare their facilities with the FDA. The FDA provides identification numbers upon active registration, but it stops short of providing Certificates of Registration. Even so, often purchasers or importers seek proof of their registration from vendors.UReg FDA Registrations can...
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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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