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...Read More

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...Read More

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...Read More

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...Read More

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,...Read More

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...Read More

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...Read More

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,...Read More

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...Read More

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...Read More