483
Gemini PharmChem Mannheim GmbHFDA 483 - Gemini PharmChem Mannheim GmbH - January 21, 2022
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During an inspection of Gemini PharmChem Mannheim GmbH, an API drug manufacturer in Mannheim, Germany, the FDA observed three issues. These included the storage of secondary packaging components in a non-GMP area, a lack of documentation for incoming material inspection checklists, and incomplete records and reports, specifically regarding deviations and raw data sheets.
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ID · e1ed594e-3ac0-40ed-8645-862e8514d073