The U.S. filed a lawsuit on August 6 seeking a permanent injunction against a Nevada business and its owners from making and selling adulterated and misbranded products, including dental cement, according to the U.S. Department of Justice (DOJ) Office of Public Affairs.
In the complaint filed in the U.S. District Court for the District of Nevada, the DOJ alleges that Gregory Steiner, Roslynn Steiner, and their company, Steiner Biotechnology, violated the U.S. Federal Food, Drug, and Cosmetic Act (FDCA) by failing to comply with current good manufacturing practices and quality system requirements. It is alleged that they sold or held for sale adulterated dental products, including synthetic bone grafting materials and dental cement, according to a press release dated August 6 from the DOJ.
Additionally, the government alleges that some of Steiners’ devices are adulterated and misbranded because premarket applications or adequate premarket notices were not provided.
“Patients deserve confidence that the medical devices they rely on are safe and effective,” Dr. Michelle Tarver, PhD, director of the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health, said in the press release. “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.”
Between 2018 and 2025, FDA investigators inspected Steiner Biotechnology’s facility at least four times and allegedly observed repeated violations of good manufacturing and quality system requirements.
The U.S. claims that the company failed 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 corrective and preventive actions to ensure that such action is effective and does not adversely affect the finished device
- Submit relevant information on identified quality problems, as well as corrective and preventive actions, for management review
Also, the FDA claims it warned the Steiners that the company was distributing class III medical devices for which they lacked an approved premarket application, a cleared premarket notification submission, or an effective investigational device exemption. Despite numerous warnings during the past seven years, the couple continued to violate the law, according to the press release.
The DOJ is seeking an injunction requiring the Steiners to implement improvements and comply with all requirements before making or selling any additional dental products.
A criminal complaint is merely an allegation. All defendants are presumed innocent until proven guilty beyond a reasonable doubt in a court of law.
