# FDA 483 - Bristol-Myers Squibb Company - May 05, 2023

Source: https://www.globalkeysolutions.net/records/483/bristol-myers-squibb-company/a7910c72-02d4-4e79-b454-32680a26de2f

> FDA 483 for Bristol-Myers Squibb Company on May 05, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bristol-Myers Squibb Company
- Inspection Date: 2023-05-05
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Bristol Myers Squibb (BMS) in Devens, Massachusetts, a drug product manufacturer, was issued a Form 483 following an FDA inspection. The inspection revealed a significant deficiency in the firm's quality system, specifically its failure to fully investigate manufacturing deviations and component failures. This included 337 "no impact" deviations that lacked root cause investigations and appropriate corrective and preventative actions.

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## Related Officers

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd