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

Source: https://www.keypedia.com/records/483/gemini-pharmchem-mannheim-gmbh/e1ed594e-3ac0-40ed-8645-862e8514d073

> FDA 483 for Gemini PharmChem Mannheim GmbH on January 21, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gemini PharmChem Mannheim GmbH
- Inspection Date: 2022-01-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [Investigator](https://www.keypedia.com/people/kham-phommachanh/cc7e728e-d2a1-469d-be3a-4f5fdd43b2dc)

Company: https://www.keypedia.com/companies/gemini-pharmchem-mannheim-gmbh/d560353e-4e8e-44be-965a-f7d431c7605d

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1