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

Source: https://www.globalkeysolutions.net/records/483/lune-group-oy-ltd/6e7f04f6-9f93-4a71-aa6d-6cc4a9287fc1

> FDA 483 for Lune Group Oy Ltd. on April 11, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Lune Group Oy Ltd.
- Inspection Date: 2023-04-11
- Product Type: device
- Office Name: International Compliance Team
- Summary: 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.

## Related Documents

- [483 - 2019-06-05](https://www.globalkeysolutions.net/records/483/lune-group-oy-ltd/1f1ec9e8-ffb8-4b2c-b6f4-79307a8a58b3)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

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

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321