# Synergy Health Radeberg GmbH – FDA 483, Sep 8, 2025

Source: https://www.keypedia.com/records/483/synergy-health-radeberg-gmbh/6c4372ae-e00e-4eaa-bf07-00c0f26f951d

> FDA 483 for Synergy Health Radeberg GmbH on September 08, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Synergy Health Radeberg GmbH
- Inspection Date: 2025-09-08
- Product Type: device
- Office Name: Division of Blood Components and Devices
- Summary: Synergy Health Radeberg GmbH, a sterilizer facility in Radeberg, Germany, received two observations during an FDA inspection. The firm failed to adequately review and revalidate process changes, specifically for Change No: 2023-019 and Change No. 2024-Minor 011. Additionally, the firm did not adequately evaluate and investigate nonconforming events NC-83600 and NC95869.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.keypedia.com/companies/synergy-health-radeberg-gmbh/ae7ed383-4669-440b-80fc-4f7a95d26e90

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917