# FDA 483 - DSAART LLC - August 05, 2021

Source: https://www.globalkeysolutions.net/records/483/dsaart-llc/bdde3ada-5cd8-4a86-a29b-40ee09a4d832

> FDA 483 for DSAART LLC on August 05, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DSAART LLC
- Inspection Date: 2021-08-05
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

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## Related Officers

- [Linda Linh N Adams](https://www.globalkeysolutions.net/people/linda-linh-n-adams/7bc1bb60-951a-4d10-84b4-c105fc857171)

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