DOJ Seeks Permanent Injunction Against Nevada's Steiner Biotechnology Over Adulterated Dental Devices
核心洞察
The U.S. Department of Justice (搜索) filed a civil complaint seeking to permanently enjoin Steiner Biotechnology LLC (搜索) from manufacturing and selling adulterated and misbranded dental products.
FDA investigators conducted at least four inspections between 2018 and 2025, finding repeated violations of current good manufacturing practice and Quality System requirements.
The company allegedly distributed Class III medical devices, including synthetic bone grafting materials and dental cement, without required premarket applications or notifications.
The U.S. Department of Justice (搜索) filed a civil complaint on August 6 in the U.S. District Court for the District of Nevada, seeking to permanently enjoin Steiner Biotechnology LLC (搜索) and its owners, Gregory S. Steiner and Roslynn L. Steiner, from manufacturing and selling adulterated and misbranded dental products. The action marks a significant escalation in a years-long regulatory standoff between the Nevada-based medical device manufacturer and federal health authorities.
The complaint alleges that Steiner Biotechnology violated the Federal Food, Drug, and Cosmetic Act (FDCA) by failing to comply with current good manufacturing practice (CGMP) and Quality System (QS) requirements. The company's dental products, which include synthetic bone grafting materials and dental cement, are sold throughout the country.
"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."
Repeated Inspection Failures Spanning Seven Years
According to the complaint, FDA investigators inspected Steiner Biotechnology's facility at least four times between 2018 and 2025 and observed repeated violations of CGMP and QS requirements. The deficiencies identified include failures to: establish and maintain adequate procedures to control device design; adequately validate processes according to established procedures; establish and maintain adequate procedures for validating 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 actions needed to correct and prevent recurrence of nonconforming product and other quality problems; verify or validate corrective and preventive actions to ensure effectiveness without adversely affecting the finished device; and submit relevant information on identified quality problems, as well as corrective and preventive actions, for management review.
Class III Devices Distributed Without Authorization
The FDA also repeatedly warned the Steiners that their company was distributing Class III medical devices without an approved premarket application, a cleared premarket notification submission, or an effective investigational device exemption. Class III devices represent the highest-risk category of medical devices and generally require premarket approval to demonstrate safety and effectiveness.
"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."
Despite numerous warnings from the FDA over the past seven years and what the complaint describes as the Steiners' repeated promises to address the violations, the company allegedly continued to violate the FDCA.
Injunctive Relief Sought
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. The case is being handled by Trial Attorney Kyu Yun Kim of the Enforcement Section of the Civil Division's Enforcement & Affirmative Litigation Branch, with assistance from 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.
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.