What is FDA Registration? Establishments or facilities that manufacture, label, package, or perform certain other operations on foods, drugs, medical devices, tobacco, or biologics are required to register with FDA. A registered facility receives a unique registration...
What are FDA import requirements? All imported FDA-regulated products must: Be manufactured, processed, packed, and held under sanitary conditions. Not be forbidden or restricted for sale in the country the product is produced or exported from. Not be adulterated...
New importers often ask, “what exactly are the steps needed to start importing FDA-regulated products”? Of course, the “steps” vary depending on the types of products you are importing, the country of origin, how the products are intended to be used, and many other...
08/12/19: FDA has recently published Import Alert 99-41, “Detention Without Physical Examination of Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance with the Requirements of the Foreign Supplier Verification Program (FSVP)...
FDA may detain an imported shipment whenever it finds a violation of the Federal Food, Drug and Cosmetic Act (“FFDCA”) via an import exam. When FDA detains the shipment, the Agency will mail a Notice of Detention (“detention notice”) to the importer and importer’s...
FDA may detain an imported product if, during an import exam, FDA finds that the product appears to violate the Federal Food, Drug and Cosmetic Act (“FFDCA”). When FDA detains the product, the Agency will mail a Notice of Detention and Hearing (“detention notice”) to...
