FDA 483 - Lune Group Oy Ltd. - June 05, 2019

The Lune Group Oy Ltd., a manufacturer of menstrual cups in Juupajoki, Finland, was cited for five observations during an FDA inspection. The deficiencies primarily concern inadequate quality system procedures, including supplier controls, device history record maintenance, and design validation. A significant issue involved the failure to submit a Medical Device Report (MDR) for a malfunction requiring medical assistance.