# FDA 483 - DSAART LLC - March 01, 2024

Source: https://www.globalkeysolutions.net/records/483/dsaart-llc/122c5b52-0b7b-4336-b4f3-af5cf1c5052f

> FDA 483 for DSAART LLC on March 01, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DSAART LLC
- Inspection Date: 2024-03-01
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: DSAART LLC in Carson City, NV, was cited for significant deficiencies in its manufacturing processes for silicone implants. The inspection revealed inadequate validation of sterilization and curing processes, incomplete risk analysis, and poorly defined production specifications. Additionally, the firm failed to properly qualify and evaluate its suppliers, indicating a systemic lack of adherence to quality system requirements.

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## Related Officers

- [Scott D. Stevens](https://www.globalkeysolutions.net/people/scott-d-stevens/8d5a611a-4f0c-4e3a-9da7-3c872b08f91e)
- [Investigator](https://www.globalkeysolutions.net/people/alexandria-l-capuano/f76c710a-613f-42b2-8958-1292fa329112)

Company: https://www.globalkeysolutions.net/companies/dsaart-llc/6d3cf257-06f9-41e1-ab93-06e44b8edc92

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b