FDA 483 - Gemini PharmChem Mannheim GmbH - January 21, 2022

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.