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

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.