# FDA 483 - Celgene International Sarl - September 15, 2017

Source: https://www.keypedia.com/records/483/celgene-international-sarl/dd34c9b9-bfdc-40a4-90f4-a52e2dfe161b

> FDA 483 for Celgene International Sarl on September 15, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Celgene International Sarl
- Inspection Date: 2017-09-15
- Product Type: drugs
- Office Name: Division of Blood Components and Devices
- Summary: Celgene International Sarl in Boudry, Switzerland, was inspected by the FDA from September 11-15, 2017. The inspection revealed a significant deficiency in control procedures for monitoring manufacturing processes, specifically regarding in-process and start-up checks for tablet and capsule production. This indicates a lack of adequate quality control to detect variability in drug product characteristics.

## Related Documents

- [483 - 2023-06-16](https://www.keypedia.com/records/483/celgene-international-sarl/7e41c20e-1772-4268-9eb2-be6641b756b4)

## Related Officers

- [Director, Enterprise Regulatory Compliance](https://www.keypedia.com/people/nicholas-a-violand/c0c3ee7a-8adb-43d2-974c-06220ef8e8eb)

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

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917