Drugs or medical devices from firms without a valid drug or medical device registration and/or listing

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 10/18/2023 updates the IA name, reason for alert, guidance, agency contacts, charge code language, and product description. Changes to the import alert are bracketed by asterisks (***). ***Complete, accurate, and up-to-date registration and listing information is critical for FDA to achieve its mission to minimize the risk and exposure of the United States public to unsafe and ineffective drugs and medical devices. According to the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act) (see section 510; 21 USC 360) and FDA regulations, an owner or operator of an establishment that is involved in the production and distribution of medical devices (21 CFR 807) and/or drugs (21 CFR 207) that are distributed in the United States (U.S.) or imported or offered for import to the U.S., must register annually with the FDA and provide product list

Quoted from the “Reason for Alert” section of the FDA page for 99-34, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.