FDA 483 - Steiner Biotechnology LLC - November 08, 2022

Steiner Biotechnology, LLC received a Form 483 with ten observations, many of which are repeat findings, highlighting significant and systemic quality system deficiencies. The firm lacks established procedures for critical areas such as design control, risk analysis, sterilization process validation, supplier evaluation, and environmental control in cleanrooms. These issues, concerning implantable bone grafting materials like OsseoConduct, Oral Bond, and Socket Graft, raise serious concerns about product quality and patient safety.