# FDA 483 - Curative Sound LLC - January 13, 2026

Source: https://www.keypedia.com/records/483/curative-sound-llc/cf284efe-aab4-48fd-86a2-fc72b8468bf5

> FDA 483 for Curative Sound LLC on January 13, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Curative Sound LLC
- Inspection Date: 2026-01-13
- Product Type: device
- Office Name: Detroit District Office
- Summary: 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.

## Related Officers

- [Melina L. Rodriguez-Upton](https://www.keypedia.com/people/melina-l-rodriguez-upton/0b540980-5708-4251-8ea6-6254375506f1)

Company: https://www.keypedia.com/companies/curative-sound-llc/0f46104f-4ce4-4dd1-a2ce-7973eae17994

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03