FDA 483 - Steiner Biotechnology LLC - February 14, 2025

Steiner Biotechnology LLC, a medical device manufacturer in Henderson, NV, received a Form 483 with twelve observations highlighting severe and systemic deficiencies in its quality management system. The inspection revealed a pervasive lack of established and adequately documented procedures across critical areas, including design control, process validation, risk analysis, quality audits, environmental control, CAPA, management review, device master records, purchasing controls, equipment qualification, device history records, and acceptance activities. Many of these issues are repeat observations from previous inspections, indicating persistent non-compliance with regulatory requirements.