483
Celgene Chemicals GmbHCelgene Chemicals GmbH – FDA 483
Record Details
An FDA inspection of Celgene Chemical GmbH, a non-sterile API manufacturer in Zofingen, Switzerland, revealed several deficiencies. These included inadequate quality agreements with third-party contractors, insufficient cleaning validation, and a deficient stability program. Additionally, issues were noted with system suitability testing and the training of temporary employees in GMP.
- Company
- Celgene Chemicals GmbH
- Product type
- drugs
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ID · 83687628-1b6d-41c1-a432-64abc51aaaf8
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