FDA 483 - FHC, Inc - November 26, 2024

An FDA inspection of FHC, Inc, a manufacturer of microTargetingTM DBS and Multi-Oblique guidance platforms, revealed significant deficiencies across multiple quality system areas. The firm was cited for inadequate design validation, uncontrolled production processes, and an insufficient risk analysis. Additionally, the organizational structure was found to be not adequately established to ensure device design and production compliance.