FDA 483 - Nutek Orthopaedics, Inc. - November 19, 2024

Nutek Orthopaedics, Inc. in Fort Lauderdale, FL, a specification developer of orthopedic medical devices, was cited for numerous significant quality system deficiencies during an FDA inspection. The inspection revealed a systemic failure to establish and follow procedures across critical areas including supplier management, document control, device history records, finished device acceptance, UDI labeling, MDR reporting, management review, quality audits, and personnel training. Many of these issues are repeat deficiencies, indicating a persistent lack of compliance with regulatory requirements.