# FDA 483 - Celgene Corporation - August 25, 2011

Source: https://www.globalkeysolutions.net/records/483/celgene-corporation/13510cf8-aa4e-466a-888f-b853453cc9f3

> FDA 483 for Celgene Corporation on August 25, 2011. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Celgene Corporation
- Inspection Date: 2011-08-25
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Celgene Corporation in Berkeley Heights, NJ, revealed two significant issues. The firm failed to include status reports for all postmarketing clinical studies in their NDA Annual Reports for products like Revlimid and Istodax. Additionally, Celgene Corporation did not report all serious and unexpected adverse drug experiences to the FDA within the required 15 calendar days, with a significant number of reports being submitted more than 100 days late.

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## Related Officers

- [D. Jeanne Denes](https://www.globalkeysolutions.net/people/d-jeanne-denes/57b95ffc-873f-4d90-9040-05fab36058f1)

Company: https://www.globalkeysolutions.net/companies/celgene-corporation/9a063de3-1691-43a3-9bf0-81da6ea21492

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248