FDA 483 - Vygon GmbH & Co. KG - September 04, 2025

Vygon GMBH & Co. KG, a medical device manufacturer in Aachen, Germany, received a Form FDA-483 with two observations. The inspection revealed significant deficiencies in the firm's corrective and preventive action procedures, specifically regarding the analysis of quality data from complaints. Additionally, the firm failed to adequately establish procedures for receiving, reviewing, and evaluating complaints, resulting in a large backlog of uninvestigated complaints.