FDA 483 - Vygon GmbH & Co. KG - September 04, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 59b20d8b-03be-46b4-89b8-c8e6c92f06e8