# FDA 483 - 3D Smile USA Inc - March 29, 2024

Source: https://www.keypedia.com/records/483/3d-smile-usa-inc/4adce331-7d1e-4b01-a5de-7cf8237f0ee6

> FDA 483 for 3D Smile USA Inc on March 29, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: 3D Smile USA Inc
- Inspection Date: 2024-03-29
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of 3D Smile USA Inc, a medical device manufacturer in New York, NY, revealed significant deficiencies in their quality system. The firm failed to maintain complaint files, adequately document corrective and preventive actions for multiple complaints, and ensure their Medical Device Reporting (MDR) procedures included device malfunctions as reportable events. These observations indicate a lack of robust controls for handling product complaints and adverse event reporting.

## Related Officers

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

Company: https://www.keypedia.com/companies/3d-smile-usa-inc/4dbaddf5-1796-47e0-902e-32c199e733ff

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