# FDA 483 - Celgene International Sarl - June 16, 2023

Source: https://www.globalkeysolutions.net/records/483/celgene-international-sarl/7e41c20e-1772-4268-9eb2-be6641b756b4

> FDA 483 for Celgene International Sarl on June 16, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Celgene International Sarl
- Inspection Date: 2023-06-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: During an inspection, Celgene International Sarl in Boudry, Switzerland, was cited for inadequate cleaning and sanitization of equipment. Specifically, a parts washing station used for drug product containers was found to have components, such as O-rings and flanges, that were not adequately cleaned, posing a risk of cross-contamination and microbial growth to drug products. This observation highlights a significant concern regarding the firm's adherence to cGMP for equipment maintenance and sanitation.

## Related Officers

- [Microbiologist](https://www.globalkeysolutions.net/people/camerson-e-moore/50733244-0d55-4b0b-a758-f192b7c66457)

Company: https://www.globalkeysolutions.net/companies/celgene-international-sarl/4b6c72e0-737a-445e-a238-7c7cc1265e65

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