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...
Aflatoxins are one of the biggest threats to producing safe, high-quality almonds that growers and processors face. Consuming almonds and other nuts contaminated with aflatoxins can increase the risk of cancer and other health problems, while a single rejected...
The U.S. FDA can detain your imported food products at any time for any reason. Whether for sampling, testing, or detention without physical examination, when your products are detained, following FDA sampling guidelines and having an FDA sampling plan is a must. You...
Everyone wants to cut in front of the line, especially when your company’s time and money depend on importing shipments as quickly and smoothly as possible. The FDA’s Import Trade Auxiliary Communications System (ITACS) allows importers to do that. FDA...
