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

An FDA inspection of Sleep Joy International LLC, a medical device manufacturer, was conducted from January 17 to January 20, 2023. The inspection resulted in a Form FDA 483, listing several significant observations indicating a lack of established quality system controls, which are essential for ensuring device safety and effectiveness. The primary issues identified included the absence of a complete Design History File for their device, intended to reduce snoring or mild to moderate obstructive sleep apnea. This critical documentation ensures proper design controls are maintained throughout the product lifecycle. Furthermore, the company had not established fundamental quality system procedures and instructions. These missing procedures encompassed vital areas such as Design Controls, Complaint Handling, Corrective and Preventive Actions, Purchasing Controls, Finished Device Acceptance, Internal Quality Audits, and Management Review Activities. Additionally, the firm failed to perform and document a risk analysis for its device, a crucial step for identifying and mitigating potential hazards. Finally, Sleep Joy International LLC had not developed written procedures for Medical Device Reporting (MDR), which are mandatory for reporting adverse events associated with medical devices. These observations highlight significant deficiencies in the company's compliance with the regulatory framework governing medical device manufacturing. In response to each observation, the company committed to implementing corrective actions. These actions are required to bring the firm into compliance with federal regulations and ensure the quality and safety of their medical devices.