# FDA 483 - SoftSmile, Inc. - February 08, 2024

Source: https://www.keypedia.com/records/483/softsmile-inc/23cc6f9f-741e-44a8-b12a-4e4afab9960d

> FDA 483 for SoftSmile, Inc. on February 08, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SoftSmile, Inc.
- Inspection Date: 2024-02-08
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: SoftSmile, Inc., a specification developer in Long Island City, NY, was inspected by the FDA from February 6-8, 2024. The inspection revealed six significant quality system deficiencies, including failures in maintaining MDR procedures, UDI database submissions, management reviews, quality audits, device master records, and design change procedures. These observations indicate a broad lack of adherence to established quality system requirements for medical devices.

## Related Officers

- [Preston M. Lee](https://www.keypedia.com/people/preston-m-lee/e44adac3-a915-4bfb-8b06-a41ea5803358)

Company: https://www.keypedia.com/companies/softsmile-inc/c20e77bd-272d-4cc0-b062-545803b36ea0

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