Bristol-Myers Squibb CompanyMay 5, 2023

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

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Record Details

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.

Company: Bristol-Myers Squibb Company
Inspection Date: May 5, 2023
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Viviana R. Ramirez
Gideon Prave
Zhongren Wu (Principal Consultant)

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ID · a7910c72-02d4-4e79-b454-32680a26de2f