Freudenberg Medical Europe GmbHOctober 30, 2025

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

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Record Details

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.

Company: Freudenberg Medical Europe GmbH
Inspection Date: October 30, 2025
Product Type: Device
Office: Office of Inspections and Investigations
Person: John A. Sciacchitano (investigator)

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ID · 5b604aaf-71d0-4628-aeee-090f21ea2970