Thermo Electron LED GmbHMarch 20, 2025

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

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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.

Company: Thermo Electron LED GmbH
Inspection Date: March 20, 2025
Product Type: Device
Office: Office of Medical Device and Radiological Health Operations
Person: Stephen D. Eich (investigator)

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ID · a95e5d99-3ad4-457c-ac46-7e5e75616359