Lune Group Oy Ltd.April 11, 2023

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

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Lune Group Oy Ltd.

Record Details

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.

Company: Lune Group Oy Ltd.
Inspection Date: April 11, 2023
Product Type: Device
Office: International Compliance Team
Person: Stephen D. Eich (investigator)

Open in Dashboard

ID · 6e7f04f6-9f93-4a71-aa6d-6cc4a9287fc1