# FDA 483 - Celgene Corporation - April 24, 2013

Source: https://www.globalkeysolutions.net/records/483/celgene-corporation/6f3a5d72-1dd3-4895-b12f-18e91179925e

> FDA 483 for Celgene Corporation on April 24, 2013. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Celgene Corporation
- Inspection Date: 2013-04-24
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Celgene Corporation's corporate headquarters in Berkeley Heights, NJ, revealed significant deficiencies in post-marketing adverse drug experience (ADE) reporting and annual report submissions. The firm failed to develop adequate written procedures for ADE surveillance and reporting, resulting in numerous late submissions of adverse event reports. Additionally, annual reports did not include status updates for all required post-marketing studies.

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## Related Officers

- [Justine C. Tomasso](https://www.globalkeysolutions.net/people/justine-c-tomasso/8a0f6e96-ae0f-47d3-a992-cff9f676e807)

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