FDA 483 - DSAART LLC - March 01, 2024

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.