Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistDavati Medical Supply LLC was warned for offering FLUZALP® QUADRIVALENT, an unapproved influenza vaccine, for sale to U.S. consumers through its website without FDA authorization. The product violated the Federal Food, Drug, and Cosmetic Act by being marketed as an unapproved new drug and misbranded biological product, lacking either an approved biologics license application (BLA) or an active investigational new drug (IND) application required for lawful distribution. The FDA took enforcement action as part of urgent measures to protect consumers from unlicensed products claiming to prevent, treat, or mitigate influenza virus infection.