# FDA 483 - Celgene Corporation - September 12, 2012

Source: https://www.globalkeysolutions.net/records/483/celgene-corporation/785beae0-f6ed-4cb5-9285-f64d1ade00b9

> FDA 483 for Celgene Corporation on September 12, 2012. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Celgene Corporation
- Inspection Date: 2012-09-12
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Celgene Corporation in Summit, NJ, revealed significant deficiencies in the conduct and oversight of a clinical investigation. Observations included failures to adhere to the investigational plan and protocols, inadequate study monitoring, and insufficient record-keeping for investigational drug disposition. These issues indicate a lack of control over critical aspects of clinical trial management.

## Related Documents

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- [483 - 2013-04-24](https://www.globalkeysolutions.net/records/483/celgene-corporation/6f3a5d72-1dd3-4895-b12f-18e91179925e)
- [483 - 2015-08-04](https://www.globalkeysolutions.net/records/483/celgene-corporation/f7303fd4-02a8-414f-9cd8-5e8a97f8bfd2)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/jonee-j-mearns/d37aa1c2-b8d8-45c8-9538-4addd81c05a7)
- [investigator](https://www.globalkeysolutions.net/people/krystal-ogunremi/f91a439d-8417-4000-9d9c-5582b882d0c8)

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