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

Source: https://www.keypedia.com/records/483/vygon-gmbh-co-kg/59b20d8b-03be-46b4-89b8-c8e6c92f06e8

> FDA 483 for Vygon GmbH & Co. KG on September 04, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Vygon GmbH & Co. KG
- Inspection Date: 2025-09-04
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2014-03-20](https://www.keypedia.com/records/warning_letter/vygon-gmbh-co-kg/244be778-d83a-4f25-93b0-ecf1b44f8d1e)

## Related Officers

- [Clifford F. Long](https://www.keypedia.com/people/clifford-f-long/846e5a0c-cb7c-421c-86aa-be9fddfbaaba)

Company: https://www.keypedia.com/companies/vygon-gmbh-co-kg/d64f5fbf-9e9a-49bb-b9f2-599a21ffd75b

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4