# FDA 483 - Soleva Pharma Llc - March 04, 2025

Source: https://www.keypedia.com/records/483/soleva-pharma-llc/189b2001-ccbe-4b7d-889e-50c26d3d1634

> FDA 483 for Soleva Pharma Llc on March 04, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Soleva Pharma Llc
- Inspection Date: 2025-03-04
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Soleva Pharma Llc, a specification developer in Robbinsville, NJ, revealed significant deficiencies across multiple areas. The firm failed to adequately establish design verification procedures for its MuGard® product's extended shelf life, lacked proper complaint handling for four patient deaths, and did not label its medical device with the required unique device identifier. These observations indicate serious non-compliance with medical device regulations.

## Related Officers

- [William R. Chang](https://www.keypedia.com/people/william-r-chang/67893bac-29e2-45b4-ba2c-1ef548781b9c)

Company: https://www.keypedia.com/companies/soleva-pharma-llc/aae3679a-a83f-4664-998e-bd715905f74c

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248