# FDA 483 - Bellaire Aesthetics Inc. - July 22, 2019

Source: https://www.keypedia.com/records/483/bellaire-aesthetics-inc/b0d0a3ca-05a0-421a-85cd-e713d027bde2

> FDA 483 for Bellaire Aesthetics Inc. on July 22, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bellaire Aesthetics Inc.
- Inspection Date: 2019-07-22
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Bellaire Aesthetics Inc. in Middle Island, NY, revealed significant deficiencies in their quality system. The firm failed to establish written procedures for controlling storage areas, managing product complaints, and developing Medical Device Report (MDR) processes. These findings indicate a lack of fundamental controls for a medical device manufacturer.

## Related Officers

- [Andrew J. Garufi](https://www.keypedia.com/people/andrew-j-garufi/567f6aaa-f6f2-45a3-9a58-80b33f3ad021)
- [Preston M. Lee](https://www.keypedia.com/people/preston-m-lee/e44adac3-a915-4bfb-8b06-a41ea5803358)

Company: https://www.keypedia.com/companies/bellaire-aesthetics-inc/f4193313-3d49-40f4-a64a-f732a0875d54

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961