# FDA 483 - Coronado Aesthetics LLC - August 22, 2025

Source: https://www.keypedia.com/records/483/coronado-aesthetics-llc/48e9ca2a-2850-4e93-9726-e73bc71c90e0

> FDA 483 for Coronado Aesthetics LLC on August 22, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Coronado Aesthetics LLC
- Inspection Date: 2025-08-22
- Product Type: device
- Office Name: Dallas District Office
- Summary: Coronado Aesthetics LLC, a class II device specification developer in Dallas, TX, received a Form 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate design validation and review procedures, a lack of management reviews, and a failure to conduct required quality audits. These issues indicate a systemic breakdown in maintaining compliance with regulatory requirements.

## Related Documents

- [483 - 2025-08-22](https://www.keypedia.com/records/483/coronado-aesthetics-llc/e3fe9f5b-f65a-4f7c-b489-1af1bb83b482)

## Related Officers

- [Yuliana Hernandez-Magana](https://www.keypedia.com/people/yuliana-hernandez-magana/450c3c39-02b7-489d-a710-e8c87c7657f4)
- [Cso](https://www.keypedia.com/people/daniel-j-lahar/d4e329c0-b6a5-42ca-acde-b79413b245ea)

Company: https://www.keypedia.com/companies/coronado-aesthetics-llc/6d9313fe-4c7e-42c6-beb5-665b578874cf

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9