# FDA 483 - Sleep Joy International LLC - January 20, 2023

Source: https://www.keypedia.com/records/483/sleep-joy-international-llc/b2b10ade-3252-422a-95fe-7e62f8197548

> FDA 483 for Sleep Joy International LLC on January 20, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sleep Joy International LLC
- Inspection Date: 2023-01-20
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Sleep Joy International LLC, a medical device manufacturer in Northport, NY, was inspected by the FDA from January 17-20, 2023. The inspection revealed significant deficiencies in the firm's quality system, including the absence of a complete Design History File and lack of established quality system procedures. Additionally, the firm failed to perform risk analysis for its snoring/sleep apnea device and had not developed written Medical Device Reporting (MDR) procedures.

## Related Officers

- [Andrew J. Garufi](https://www.keypedia.com/people/andrew-j-garufi/567f6aaa-f6f2-45a3-9a58-80b33f3ad021)

Company: https://www.keypedia.com/companies/sleep-joy-international-llc/883656db-56f0-406c-b403-37d5ef54cdde

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