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 food importers and exporters. We’ll also provide a general understanding of the entire food import process....
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...
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,...
Although the risk of allergen cross contact is well understood, the addition of sesame to FDA’s “big nine” list of Major Food Allergens required a renewed focus on preventive allergen controls and validated/verified food allergen testing methods to detect...
Enlisting an import agent is a basic requirement for importers of FDA-regulated products. Import agents are the frontlines of communication with the FDA, assisting with the submission of required registrations and listings as well as support with questions posed by...
Sterility testing and assurance are critical regulatory compliance requirements for 503B facilities that perform sterile compounding according to USP <797>. Subject to section 503B under the Federal Food, Drug, and Cosmetic (FD&C) Act, 503B facilities...
