FDA 483 - Rhausler Inc - December 20, 2024

Rhausler Inc. in Fremont, CA, was inspected regarding its manufacturing of the Class 2 Rhausler Cervical Vertebrae Plating System. The inspection revealed significant deficiencies across its quality management system, including failures in procedure establishment, CAPA documentation, complaint handling, internal audits, management review documentation, and personnel training. These issues indicate a systemic lack of adherence to quality system requirements.