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Sol-Millennium Medical, Inc. was cited for distributing sterile and non-sterile syringes and needles without required FDA approval, violating section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act by failing to obtain either a premarket approval (PMA) or investigational device exemption (IDE) before commercial distribution. During a December 2023 inspection, FDA investigators determined the company was operating as a specification developer, initial importer, and complaint file establishment for these injection/aspiration devices while lacking the necessary premarket authorization. The devices were also found to be misbranded under section 502(o) of the Act due to their introduction into interstate commerce without proper approval documentation.