# FDA 483 - Thermo Electron LED GmbH - March 20, 2025

Source: https://www.keypedia.com/records/483/thermo-electron-led-gmbh/a95e5d99-3ad4-457c-ac46-7e5e75616359

> FDA 483 for Thermo Electron LED GmbH on March 20, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Thermo Electron LED GmbH
- Inspection Date: 2025-03-20
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Thermo Electron LED GmbH, a medical device manufacturer in Langenselbold, Germany, revealed two significant observations. The firm failed to adequately control non-conforming products, specifically lacking documentation for rework and retesting. Additionally, procedures for ensuring purchased products and services conform to requirements were not adequately established, as evidenced by issues with supplier management and agreements.

## Related Officers

- [investigator](https://www.keypedia.com/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.keypedia.com/companies/thermo-electron-led-gmbh/93401e9f-4f01-48b9-ba6c-eec588459ff6

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