# FDA 483 - Advance-Esthetic LLC - March 15, 2022

Source: https://www.keypedia.com/records/483/advance-esthetic-llc/f964d9d5-d273-4089-bd79-8d1e24422b1e

> FDA 483 for Advance-Esthetic LLC on March 15, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advance-Esthetic LLC
- Inspection Date: 2022-03-15
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Advance-Esthetic LLC, an initial importer in Fort Lauderdale, FL, was cited for numerous significant quality system deficiencies during an FDA inspection. The firm failed to establish fundamental procedures for design control, complaint handling, medical device reporting, corrective and preventive actions, acceptance activities, nonconforming product control, and purchasing controls. Additionally, several Class IV laser products lacked required certification labels, hazard warnings, and proper labeling in user manuals and on websites.

## Related Documents

- [483 - 2024-02-07](https://www.keypedia.com/records/483/advance-esthetic-llc/84db9546-53bb-411d-a721-8fedc99a22e9)

## Related Officers

- [Ebony D. Sanon](https://www.keypedia.com/people/ebony-d-sanon/703dc125-1019-43d1-9598-1bdc92026e2b)
- [investigator](https://www.keypedia.com/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

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