Affordable Healthcare Solutions, LLC, d/b/a Affordable Healthcare Solutions 1, LLC has pled guilty and was sentenced in South Florida federal court to Receiving Adulterated Devices in Interstate Commerce and Delivery for Pay with Intent to Defraud or Mislead, in violation of 21 USC 331(c) and 333(a)(2). According to the facts admitted at the change of plea, on May 11, 2016, Special Agents with the United States Food and Drug Administration, Office of Criminal Investigations, executed a search warrant at Affordable Healthcare Solutions 1, LLC (Affordable Healthcare), a business managed by R.A. During the search, agents located and seized unapproved, foreign-market Supartz Euflexxa, Synvisc, Synvisc-One, and Orthovisc, which are prescription hyaluronic acid (HA) medical devices intended for the treatment of pain in osteoarthritis of the knee that must be injected by a doctor or other qualified healthcare professional. Because these prescription medical devices lacked FDA approval for distribution and use in the United States, they were adulterated.
