Steiner Biotechnology, LLC

Warning LetterOpen

Gregory G. Steiner, DDS CEO Steiner Biotechnology, LLC 1051 Olsen Street, Suite 3611 Henderson , NV 89011 United StatesFEI 3005138409Issued May 19, 2023Center for Devices and Radiological Health

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3005138409.

Violations20

Issue DateMay 19, 2023

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Steiner Biotechnology, LLC
Location: Gregory G. Steiner, DDS CEO Steiner Biotechnology, LLC 1051 Olsen Street, Suite 3611 Henderson , NV 89011 United States
FEI Number: 3005138409
Country: United States
Issue Date: May 19, 2023
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

Steiner Biotechnology manufactured multiple implantable bone grafting devices (including Socket Graft, OsseoConduct, and Ridge Graft Kit) that the FDA found to be adulterated due to failure to comply with current good manufacturing practice requirements under 21 CFR Part 820. During inspections in August and November 2022, investigators identified violations including failure to establish and maintain adequate procedures to control device design to ensure specified design requirements were met. The company's November 2022 response to these observations was deemed inadequate by the FDA.

Steiner Biotechnology, LLC FDA Warning Letter, May 19, 2023