# FDA 483 - Advance-Esthetic LLC - November 06, 2025

Source: https://www.keypedia.com/records/483/advance-esthetic-llc/c0e084c6-7d70-499b-b46a-e0b88bf946e4

> FDA 483 for Advance-Esthetic LLC on November 06, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advance-Esthetic LLC
- Inspection Date: 2025-11-06
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Advance-Esthetic LLC, an initial importer/distributor of medical devices, received a Form FDA 483 with six observations. The inspection revealed significant deficiencies in corrective and preventive action procedures, complaint handling, and regulatory reporting for non-compliant electronic products. Additionally, the firm failed to submit timely annual reports, establish adequate purchasing data requirements, and include required warnings in marketing materials for laser products.

## Related Documents

- [483 - 2022-03-15](https://www.keypedia.com/records/483/advance-esthetic-llc/f964d9d5-d273-4089-bd79-8d1e24422b1e)
- [483 - 2024-02-07](https://www.keypedia.com/records/483/advance-esthetic-llc/84db9546-53bb-411d-a721-8fedc99a22e9)

## Related Officers

- [Monica C. Burgos Garcia](https://www.keypedia.com/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)

Company: https://www.keypedia.com/companies/advance-esthetic-llc/76e7e45c-1039-48b6-967a-c69297d999db

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6