483
Thermo Electron LED GmbHThermo Electron LED GmbH – FDA 483, Mar 20, 2025
Record Details
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.
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ID · a95e5d99-3ad4-457c-ac46-7e5e75616359
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