483
Freudenberg Medical Europe GmbHFreudenberg Medical Europe GmbH – FDA 483, Oct 30, 2025
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.
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ID · 5b604aaf-71d0-4628-aeee-090f21ea2970
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