FDA 483 - Gerresheimer Regensburg GmbH - October 24, 2022

Gerresheimer Regensburg GmbH, a contract manufacturer in Pfreimd, Germany, was inspected and cited for significant deficiencies in its quality system. Observations included inadequate process validation for plastic ejection molding, deficiencies in device history records, issues with design transfer, and an internal audit schedule that did not accurately reflect the firm's activities. These issues indicate a lack of control over critical manufacturing processes and quality system elements.