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

Source: https://www.keypedia.com/records/483/lune-group-oy-ltd/1f1ec9e8-ffb8-4b2c-b6f4-79307a8a58b3

> FDA 483 for Lune Group Oy Ltd. on June 05, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lune Group Oy Ltd.
- Inspection Date: 2019-06-05
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

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## Related Officers

- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/lune-group-oy-ltd/4bcb35d1-965d-4823-aff2-ba4e500f7930

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd