# FDA 483 - Advance-Esthetic LLC - February 07, 2024

Source: https://www.globalkeysolutions.net/records/483/advance-esthetic-llc/84db9546-53bb-411d-a721-8fedc99a22e9

> FDA 483 for Advance-Esthetic LLC on February 07, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advance-Esthetic LLC
- Inspection Date: 2024-02-07
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Advance-Esthetic LLC, a medical device manufacturer in Fort Lauderdale, FL, received 15 observations during an FDA inspection, with several being repeat findings. The inspection revealed widespread deficiencies in the firm's quality system, including inadequate procedures for laser product controls, nonconforming product, acceptance activities, device master records, complaint handling, and corrective and preventive actions. These issues indicate a systemic failure to establish and implement essential quality system requirements for medical device manufacturing.

## Related Documents

- [483 - 2022-03-15](https://www.globalkeysolutions.net/records/483/advance-esthetic-llc/f964d9d5-d273-4089-bd79-8d1e24422b1e)

## Related Officers

- [Ebony D. Sanon](https://www.globalkeysolutions.net/people/ebony-d-sanon/703dc125-1019-43d1-9598-1bdc92026e2b)
- [Gisselle I. Sensebe](https://www.globalkeysolutions.net/people/gisselle-i-sensebe/fbf83976-9888-44c0-a381-1993a933df4a)
- [Investigator ](https://www.globalkeysolutions.net/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

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

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