# FDA 483 - Freudenberg Medical Europe GmbH - October 30, 2025

Source: https://www.keypedia.com/records/483/freudenberg-medical-europe-gmbh/5b604aaf-71d0-4628-aeee-090f21ea2970

> FDA 483 for Freudenberg Medical Europe GmbH on October 30, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Freudenberg Medical Europe GmbH
- Inspection Date: 2025-10-30
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Freudenberg Medical Europe GmbH in Kaiserslautern, Germany, revealed significant deficiencies in the firm's quality system. Observations included inadequately established procedures for corrective and preventive actions (CAPA) and insufficient controls for environmental conditions in cleanrooms. These issues indicate a need for improved procedural clarity and systematic approaches to quality management.

## Related Officers

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

Company: https://www.keypedia.com/companies/freudenberg-medical-europe-gmbh/ba402628-9028-40dd-8699-5730769e260d

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8