# FDA 483 - Bristol-Myers Squibb Company - July 30, 2012

Source: https://www.keypedia.com/records/483/bristol-myers-squibb-company/10c364b5-0a3f-4a9c-9052-a72355ca9483

> FDA 483 for Bristol-Myers Squibb Company on July 30, 2012. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bristol-Myers Squibb Company
- Inspection Date: 2012-07-30
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Celgene Corporation's Summit, NJ facility revealed two significant issues. The firm failed to thoroughly review unexplained discrepancies, specifically concerning an off-white appearance defect in Azacitidine for Injection lots. Additionally, there was no written program for assessing drug product stability, and numerous Revlimid Capsule stability samples were not properly logged into stability chambers.

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## Related Officers

- [Jose M. Cayuela](https://www.keypedia.com/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)
- [Justine C. Tomasso](https://www.keypedia.com/people/justine-c-tomasso/8a0f6e96-ae0f-47d3-a992-cff9f676e807)

Company: https://www.keypedia.com/companies/bristol-myers-squibb-company/3734a119-014f-49c6-b518-fc8b1dea7f92

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