FDA 483 - DSAART LLC - August 05, 2021

During an inspection, PSAART, LLC dba Alpha Aesthetics, a manufacturer of silicone implants and cannulas in Carson City, NV, was cited for ten significant quality system deficiencies. These issues include failures in Medical Device Reporting, process validation (sterilization, curing, heat sealing), complaint handling, design control, purchasing control, corrective and preventive actions, process parameter monitoring, equipment calibration, management review, and device history records. Several observations were repeats from previous FDA inspections, indicating systemic and persistent non-compliance.