483
SpineFrontier, Inc.SpineFrontier, Inc. – FDA 483, Apr 2, 2026
Record Details
An FDA inspection of SpineFrontier, Inc. dba LESpine Innovations in Burlington, MA, from March 30 to April 2, 2026, identified one observation. The firm failed to adequately maintain records of corrective actions, specifically regarding the documentation and cross-referencing of CAPA 404 with related complaints concerning issues with set screw locking during surgical procedures. This indicates a deficiency in their quality system for complaint handling and corrective actions.
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