One of the most challenging aspects of doing business in the U.S. is navigating the many and varied regulatory requirements of U.S. agencies. When working with food imports overseen by the Food and Drug Administration (FDA) and United States Department of Agriculture...
Import alerts notify U.S. Food & Drug Administration (FDA) personnel that the agency has sufficient evidence that a product coming into the country may be in violation of FDA regulations. The source of the violation may be the product itself, the manufacturer,...
1-Minute Summary The FDA’s “Big List” includes nine major allergens, highlighting the need for accurate labeling and allergen controls in food manufacturing. Effective allergen controls and preventive measures are essential under the Food Safety...
503B sterile compounding pharmacies are ultimately responsible for their products, even when they outsource quality and sterility testing. Here’s how to ensure your testing partner uses adequate laboratory controls so you can remain compliant and produce safe,...
Expediting imports of your FDA-regulated products keeps you a step ahead of the competition, with accurate and complete import entry documentation submitted to FDA critical to that success. So, why are so many importers still making costly errors in advanced shipment...
In this post, we will cover a few important points about U.S. customs, the U.S. Food and Drug Administration (FDA) and some modern-day challenges faced by importers and exporters. We’ll also provide a general understanding of the entire food import process. Here’s...
