# FDA 483 - Bristol-Myers Squibb Company - December 06, 2024

Source: https://www.globalkeysolutions.net/records/483/bristol-myers-squibb-company/97218ac0-74e3-4a85-83a2-081a9e0504fb

> FDA 483 for Bristol-Myers Squibb Company on December 06, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bristol-Myers Squibb Company
- Inspection Date: 2024-12-06
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Bristol-Myers Squibb Company, located in Madison, NJ, received a Form 483 for deficiencies in its Risk Evaluation and Mitigation Strategy (REMS) for THALOMID. The inspection revealed failures in adhering to the REMS audit schedule, monitoring patient pregnancy tests, and providing complete training materials to healthcare providers and pharmacies. These issues indicate a lack of robust controls in ensuring the safe use and distribution of the drug.

## Related Documents

- [EIR - 2006-08-14](https://www.globalkeysolutions.net/records/eir/bristol-myers-squibb-company/991b0c74-c74b-45a6-915a-36b05b26ce5d)
- [EIR - 2022-03-14](https://www.globalkeysolutions.net/records/eir/bristol-myers-squibb-company/d539f239-1103-4fe2-acdf-a6f28938d6e1)
- [483 - 2021-02-19](https://www.globalkeysolutions.net/records/483/bristol-myers-squibb-company/de025911-4ac0-4553-854c-d1edad23420a)
- [483 - 2025-07-18](https://www.globalkeysolutions.net/records/483/bristol-myers-squibb-company/3f16d573-7ac8-419f-9ff4-2b070cead434)
- [483 - 2017-01-25](https://www.globalkeysolutions.net/records/483/bristol-myers-squibb-company/d9ab1e53-7ce9-4a8c-b38e-01f5e565a0ed)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/tyanna-n-hadley/8fdebfd7-d6f3-44ab-9dcb-864ab6d55d53)

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

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