FDA 483 - Lune Group Oy Ltd. - April 11, 2023

An FDA Form 483 was issued to Lune Group Oy Ltd. in Juupajoki, Finland, following an inspection from April 11-14, 2023. The inspection revealed significant deficiencies related to the firm's corrective and preventive action procedures and the timely submission of Medical Device Reports (MDRs) for serious injuries associated with their Lunette Menstrual cups. Additionally, the risk analysis for the menstrual cup was found to be inadequate.