# FDA 483 - Bristol-Myers Squibb Company - July 18, 2025

Source: https://www.keypedia.com/records/483/bristol-myers-squibb-company/3f16d573-7ac8-419f-9ff4-2b070cead434

> FDA 483 for Bristol-Myers Squibb Company on July 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bristol-Myers Squibb Company
- Inspection Date: 2025-07-18
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Celgene Corporation in Summit, NJ, revealed significant deficiencies in the manufacturing of sterile drug products, Breyanzi and Abecma. Observations included failures in aseptic processing procedures, inadequate environmental monitoring, and insufficient investigation of discrepancies. The facility also exhibited issues with building maintenance and equipment qualification, indicating a lack of control over critical manufacturing processes.

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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