# FDA 483 - Bristol-Myers Squibb Company - July 08, 2025

Source: https://www.globalkeysolutions.net/records/483/bristol-myers-squibb-company/939abfe3-3ecc-4e4d-8c08-1fef2cc2e38d

> FDA 483 for Bristol-Myers Squibb Company on July 08, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bristol-Myers Squibb Company
- Inspection Date: 2025-07-08
- Product Type: biologics
- Office Name: New England District Office
- Summary: Bristol-Myers Squibb Company in Devens, MA, was cited for four observations related to its biologic drug substance manufacturing. The inspection revealed significant issues including recurrent mold contamination in manufacturing and storage areas, inadequate qualification of critical equipment, deficiencies in raw material specifications and sampling plans, and a failure to properly investigate manufacturing deviations and component failures. These issues indicate a lack of robust quality control and environmental management.

## Related Documents

- [483 - 2023-05-05](https://www.globalkeysolutions.net/records/483/bristol-myers-squibb-company/a7910c72-02d4-4e79-b454-32680a26de2f)

## Related Officers

- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.globalkeysolutions.net/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)
- [Armen H. Youssoufian](https://www.globalkeysolutions.net/people/armen-h-youssoufian/47aa0283-ca67-4aec-8ac1-7d4cb222eb04)
- [Deputy Director](https://www.globalkeysolutions.net/people/lori-m-newman/a0e448e4-11ba-4095-b879-feabb8750b3f)
- [Armen Youssoufian](https://www.globalkeysolutions.net/people/armen-youssoufian/61211f8d-64a8-4d38-af4c-9c71281964c1)

Company: https://www.globalkeysolutions.net/companies/bristol-myers-squibb-company/b20ef646-d409-4268-af48-ddf4c16f82cc

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144