The United States filed a complaint today seeking to permanently enjoin a Nevada-based medical device manufacturer from manufacturing and selling adulterated and misbranded products.
In a civil complaint for permanent injunction filed on Aug. 6, the United States alleges that Gregory S. Steiner and Roslynn L. Steiner (the Steiners), and their company, Steiner Biotechnology LLC., violate the Federal Food, Drug, and Cosmetic Act (FDCA) by failing to comply with current good manufacturing practice (CGMP) and Quality System (QS) requirements and by selling or holding for sale dental products, including synthetic bone grafting materials and dental cement, that are adulterated. Some of the Steiners’ devices are also adulterated and misbranded for failing to submit premarket applications or adequate premarket notices for their devices.
“Today’s action reflects the Department of Justice’s ongoing commitment to safeguarding patients and maintaining accountability within the medical device industry,” said Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division. “When medical device manufacturers fail to meet their obligations under federal law, we will take appropriate steps to ensure patient safety.”
“Patients deserve confidence that the medical devices they rely on are safe and effective, said Michelle Tarver, M.D., Ph.D., Director of the FDA’s Center for Devices and Radiological Health. “The FDA is committed to holding manufacturers accountable when they fail to meet federal requirements and will continue working to safeguard patients and protect the public health.”
The complaint, which was filed in the U.S. District Court for the District of Nevada, alleges FDA investigators inspected Steiner Biotechnology’s facility at least four times from 2018 to 2025 and observed repeated violations of CGMP and QS requirements, such as failing to: establish and maintain adequate procedures to control the design of the device; adequately validate processes according to established procedures; establish and maintain adequate procedures for validating the device design, including risk analysis; establish and maintain procedures to adequately control environmental conditions; adequately maintain and implement procedures to fully investigate the cause of nonconformities relating to product, processes, and the quality system; identify the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems; verify or validate the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device; and to submit relevant information on identified quality problems, as well as corrective and preventive actions, for management review.
FDA also repeatedly warned the Steiners that their company was distributing Class III medical devices for which they do not have an approved premarket application, a cleared premarket notification submission, or an effective investigational device exemption. Despite numerous warnings from FDA over the past seven years and the Steiners’ repeated promises, the Steiners continue to violate the FDCA.
According to the complaint, Steiner Biotechnology’s dental products are sold throughout the country. The government’s lawsuit seeks injunctive relief requiring the Steiners to implement sanitation and process improvements and to comply with the FDCA’s requirements before manufacturing or distributing any additional dental products.
Trial Attorney Kyu Yun Kim of the Enforcement Section of the Civil Division’s Enforcement & Affirmative Litigation Branch is handling the case with the assistance of Assistant U.S. Attorney Virginia T. Tomova for the District of Nevada, and Associate Chief Counsel Leah A. Edelman in FDA’s Office of the Chief Counsel.
Additional information about the Enforcement & Affirmative Litigation Branch and its enforcement efforts may be found at www.justice.gov/civil/enforcement-affirmative-litigation-branch .
The claims made in the complaint are allegations that, if the case were to proceed to trial, the government must prove by a preponderance of the evidence.