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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.