# FDA 483 - Aesthetics Biomedical, Inc. - January 21, 2020

Source: https://www.keypedia.com/records/483/aesthetics-biomedical-inc/1d60eb1b-c2fc-4e6a-be0b-848f261f8cf8

> FDA 483 for Aesthetics Biomedical, Inc. on January 21, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aesthetics Biomedical, Inc.
- Inspection Date: 2020-01-21
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Aesthetics Biomedical, Inc., an initial importer and distributor of the Class II Vivace Fractional Microneedle RF System, was inspected by the FDA. The inspection revealed significant deficiencies in the firm's quality system, specifically the lack of established written procedures for critical activities such as Medical Device Reporting, servicing, rework of nonconforming products, and overall document control. These findings indicate a severe lack of foundational quality system controls.

## Related Officers

- [Eric C. Fox](https://www.keypedia.com/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)

Company: https://www.keypedia.com/companies/aesthetics-biomedical-inc/fc01a86f-b588-40d9-98a0-1b687cb7de35

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6