DSAART LLCMarch 1, 2024

FDA 483 - DSAART LLC - March 01, 2024

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Record Details

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.

Company: DSAART LLC
Inspection Date: March 1, 2024
Product Type: Device
Office: Division of Human and Animal Food Operations - West V
People: Scott D. Stevens
Alexandria L. Capuano (Investigator)

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ID · 122c5b52-0b7b-4336-b4f3-af5cf1c5052f