Food facility registration renewal under Section 415 of the FD&C Act closes December 31, 2026, ending the biennial window that opens October 1, 2026. Facilities missing this deadline face registration cancellation and lose authorization to manufacture, process, pack, or store …
Foreign device manufacturers must designate one U.S. agent through FDA’s Unified Registration and Listing System as part of annual establishment registration under 21 CFR Part 807. This agent serves as FDA’s official point of contact, receiving communications and, when designated, …
Missed FDA registration or U.S. Agent deadlines expose foreign manufacturers to import detention, listing suspension, and removal from FDA’s registered facility database. Food facilities that skip the biennial October 1–December 31 renewal lose registration status entirely, halting shipments to U.S. …
Facility registration renewal is due biennially, with the first renewal deadline set for July 1, 2026, following initial registration by July 1, 2024. FDA charges no government fee for registration or listing, though foreign facilities must maintain a designated U.S. …
FDA warning letters in 2026 continue targeting compounding pharmacies. Telehealth operators, with a notable wave issued June 18, 2026, alongside sustained enforcement against online GLP-1 marketing—facilities. Products must maintain accurate FDA registration and listing to avoid triggering these actions. Foreign …
FDA import alerts can stop shipments at the border and disrupt your operations. These alerts indicate potential violations that may lead to detention of goods, lost revenue, and added logistics costs. This article walks through why import alerts happen, how …
Navigating FDA labeling rules can feel overwhelming for manufacturers and brand teams in the food and dietary supplement space. Because misbranding carries legal exposure and risks to consumer safety, companies need clear, practical guidance to get labels right. This article …
Receiving an FDA warning letter is stressful and urgent for any company operating in regulated spaces. These letters point to specific compliance gaps and, if left unaddressed, can lead to costly enforcement. This guide lays out a clear, practical path …
The regulatory framework for dietary supplement claims is set by the FDA to protect consumers and promote truthful marketing. This article explains the differences among structure/function claims, health claims, and disease claims, and outlines the definitions, regulatory requirements, and business …
FDA compliance services help companies operating in food, drug, and cosmetic markets navigate federal rules and reduce regulatory risk. These services make sure products meet safety and performance expectations and help protect public health. With regulators increasing scrutiny, a clear …