DOJ seeks to halt Nevada firm’s manufacture, sale of dental products

The U.S. Department of Justice has filed a complaint seeking to permanently stop a Nevada medical device manufacturer from manufacturing and selling dental products that the government alleges are adulterated and misbranded.

The civil complaint for permanent injunction, filed in the U.S. District Court for the District of Nevada, alleges that Gregory S. Steiner and Roslynn L. Steiner and their company, Steiner Biotechnology LLC, violated the Federal Food, Drug, and Cosmetic Act.

According to the complaint, the company sells dental products throughout the country, including synthetic bone grafting materials and dental cement. The government alleges the products are adulterated because the defendants failed to comply with current good manufacturing practice and Quality System requirements. Some of the company's devices are also allegedly adulterated and misbranded because the defendants failed to submit required premarket applications or adequate premarket notices.

The complaint alleges U.S. Food and Drug Administration investigators inspected Steiner Biotechnology's facility at least four times between 2018 and 2025 and observed repeated violations of manufacturing and quality requirements.

Among the alleged violations were failures to establish and maintain adequate procedures for device design controls and design validation, including risk analysis; adequately validating processes; establishing and maintaining procedures to adequately control environmental conditions; and fully investigate the causes of nonconformities involving products, processes and the quality system.

The government also alleges the company failed to identify actions needed to correct and prevent recurring quality problems, verify or validate corrective and preventive actions, and submit relevant information about quality problems and corrective and preventive actions for management review.

According to the complaint, the FDA also repeatedly warned the Steiners that their company was distributing Class III medical devices without an approved premarket application, cleared premarket notification submission or effective investigational device exemption. The Justice Department alleges the violations continued despite numerous FDA warnings during the past seven years and repeated promises by the Steiners.

"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."

The government is seeking an injunction requiring the Steiners to implement sanitation and process improvements and comply with FDCA requirements before manufacturing or distributing additional dental products.

The claims in the complaint are allegations. If the case proceeds to trial, the government must prove them by a preponderance of the evidence.