FDA 483 - Steiner Biotechnology LLC - February 01, 2024

Steiner Biotechnology LLC, a manufacturer of sterile bone grafting materials in Henderson, NV, received 11 observations during an FDA inspection from January 22 to February 1, 2024. The inspection revealed significant and recurring deficiencies across its quality system, including inadequate design verification, unvalidated sterilization processes, and poor environmental controls for its cleanroom. Repeat observations from previous inspections and prior enforcement actions highlight a persistent failure to address critical quality system requirements.