# FDA 483 - Elegant Direct Corp - November 10, 2021

Source: https://www.keypedia.com/records/483/elegant-direct-corp/2bf2c501-31ed-435e-9126-17a897b42b25

> FDA 483 for Elegant Direct Corp on November 10, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elegant Direct Corp
- Inspection Date: 2021-11-10
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Elegant Direct Corp, a medical device manufacturer in Brooklyn, NY, revealed significant deficiencies in their quality system. The firm was cited for failing to establish written procedures for handling serious injuries and deaths, managing consumer complaints, and implementing corrective and preventive actions for non-conforming medical devices. These observations indicate a fundamental lack of essential operational controls.

## Related Officers

- [investigator](https://www.keypedia.com/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.keypedia.com/companies/elegant-direct-corp/5059b246-291e-4c38-81d3-85e5546c8beb

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