FDA WARNING_LETTER - Davati Medical Supply LLC - June 22, 2021

The FDA issued a Warning Letter to Davati Medical on June 25, 2021, following a review of their website, www.davatimedical.com, on June 22, 2021. The company was found to be offering FLUZALP® QUADRIVALENT, Influenza Vaccine, for sale in the United States, claiming it mitigates, prevents, treats, diagnoses, or cures Influenza Virus.

The FDA determined that FLUZALP® QUADRIVALENT is an unapproved new drug under section 505 of the FD&C Act (21 U.S.C. § 355) and a misbranded drug under section 502 of the FD&C Act (21 U.S.C. § 352). Furthermore, it is an unlicensed biological product under section 351 of the PHS Act (42 U.S.C. § 262), as it lacks an approved biologics license application (BLA) or an investigational new drug (IND) application.

Examples of misleading claims on the website include statements about the product's indication for active immunization, protection duration, and false assertions of FDA testing and approval. Davati Medical is required to immediately cease the sale of this unlicensed, unapproved, and unauthorized product. They must respond within 48 hours via email to CBERDCMRecommendations@fda.