PAJUNK GMBH MEDIZINTECHNOLOGIE – FDA 483, Feb 6, 2025

PAJUNK GMBH MEDIZINTECHNOLOGIE, a medical device manufacturer in Geisingen, Germany, was cited for three observations during an FDA inspection. The firm's procedures for corrective and preventive actions, labeling control, and complaint handling were found to be inadequately established. These deficiencies indicate a lack of robust quality system controls, particularly concerning root cause analysis, label integrity, and the evaluation and reporting of potential Medical Device Reports.