LAS VEGAS (KTNV) — A Henderson company is being accused of manufacturing and selling adulterated and misbranded dental products in a new lawsuit filed by the Department of Justice.
According to court documents, this involves Steiner Biotechnology LLC, which is run by Gregory and Roslynn Steiner.
Prosecutors allege they are violating the Federal Food, Drug, and Cosmetic Act and aren't complying with current good manufacturing practice and quality system requirements by selling or holding for sale dental products that are low quality and don't follow FDA standards.
Products allegedly included synthetic bone grafting materials and dental cement.
"FDA inspected Defendants' facility between February 3-14, 2025. This inspection revealed numerous violations of the Act and its implementing regulations," court documents read in part. "
Prosecutors also accused the Steiners of distributing devices that they don't have approval to sell and/or have improperly modified.
"Changes have been made to the Socket Graft Plus device's chemical composition and design that could significantly affect the device's safety or effectiveness, and Defendants have neither received FDA approval of a PMA application for the modified device nor obtained clearance of a 510(k) for the modified device, as required by [law]," documents state. "Further, Defendants are making intended use claims for the Socket Graft Plus device that are not in the cleared 510(k)s and constitute a major change or modification in the device's intended use."
This is not the first time that facility has been inspected and FDA officials have previously found violations.
During the 2018, 2022, and 2024 inspections, FDA investigators "observed numerous violations" including, but not limited to, design controls, process validation, corrective and preventative action, and production and process controls.
"Despite numerous warnings from FDA over the past seven years and Defendants' repeated promises to correct the numerous ongoing violations, Defendants continue to violate the Act," court filings state. "Based on Defendants' conduct, Plaintiff believes that, unless restrained by order of this Court, Defendants will continue to violate [the law]."
Prosecutors are asking the court to prevent the company from manufacturing, processing, packing, holding, labeling or distributing any device at or from their Henderson facility until they can get everything in compliance with FDA regulations.
"Patients deserve confidence that the medical devices they rely on are safe and effective," said Dr. Michelle Tarver, 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 public health."
According to the complaint, Steiner Biotechnology's dental products are sold throughout the country.
No future court hearings are scheduled as of Monday afternoon.
You can read the full complaint below.