FDA 483 - Curative Sound LLC - January 13, 2026

Curative Sound LLC, a medical device manufacturer in Carmel, IN, was inspected and cited for significant deficiencies in its quality system. Observations included a lack of established design control procedures, specifically incomplete design and development requirements, and inadequate risk analysis with inconsistent severity scores for identified harms. Additionally, production processes for the CS-Pro MED device were not fully developed, with critical manufacturing work instructions still pending release.