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December 2020
Previously we talked about medical device registration, Today, we’re sharing some insight on the human drug products process. The first thing you’ll need to do is obtain a DUNS number. If the drug product is finished and under OTC monograph, you can proceed to the labeling. If it is not under OTC monograph, then you...
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Are you looking to register medical devices? If so, there are certain steps you should take to ensure the most straightforward and error-free process. To help you get started, this handy guide may provide some useful information. For starters, you should start by identifying which product class your medical device belongs to: Class one, two,...
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Beneath the U.S. The Food Traceability Proposed Rule of the FDA can require people who grow, package, process, or store food on the Food Traceability List (FTL) of the FDA to control and record Key Data Elements (KDEs) at Critical Tracking Events (CTEs). Some of the foods that can be found on the FTL include...
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For any imports of food, drinks, and nutritional supplements entering the United States, the Food and Drug Administration (FDA) requires the submission of what’s called Prior Notice. The FDA will release a confirmation number in the form of a barcode following receipt of the Prior Notice, which would accompany the majority of food shipments. Filing...
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The term “food facility” is broad and although many of these facilities must register with the FDA, there may be scenarios or certain facilities that don’t need to register. If you’re having trouble figuring it out, we’re making it easier to determine whether or not it’s required. If your food facility, manufactures, packs, labels, processes,...
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I visited the THAT Brewery Production Facility in Cottonwood (http://thatbrewery.com/) to take some photos for the owners. It was exciting to see the new canning line in operation, assembling this stack of Arizona Trail Ale. It’s available in Whole Foods in Arizona and many other local stores (including mine, the Ponderosa Market in Pine) The...
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As a reminder, U.S. and foreign facilities for human and animal food must renew their registration with the U.S. Food and Drug Administration before December 31st, provided they are required to register. The FDA stated in a news release that if the facility fails to renew its registration by the deadline date, the agency will...
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The FDA has had to deal with a major juggling act this year as it deals with the pandemic. Changes in facility activities also significantly influenced food processing operations. Due to this, the FDA has permitted some degree of leniency in the packaging of eggs, the labeling of ingredients and the sale directly to customers...
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