# FDA 483 - Celgene Chemicals GmbH - Unknown Date

Source: https://www.keypedia.com/records/483/celgene-chemicals-gmbh/83687628-1b6d-41c1-a432-64abc51aaaf8

> FDA 483 for Celgene Chemicals GmbH on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Celgene Chemicals GmbH
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: 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.

## Related Officers

- [Sandra A. Hughes](https://www.keypedia.com/people/sandra-a-hughes/ee1b9542-fe28-4618-a666-67a1ff736481)

Company: https://www.keypedia.com/companies/celgene-chemicals-gmbh/c8dbcd47-df3e-457b-b655-e0b653a503a1

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4