Bristol-Myers Squibb Holdings Pharma Ltd. Liability CompanyJuly 12, 2021

FDA 483 - Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company - July 12, 2021

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Record Details

Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company received a Form 483 citing significant deficiencies across its quality systems, laboratory controls, and manufacturing processes. Key issues include data integrity failures, inadequate quality unit oversight, microbiological contamination risks, and insufficient design verification for combination products. The firm also struggled with pest control and proper handling of incoming materials, indicating systemic control weaknesses.

Company: Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company
Inspection Date: July 12, 2021
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West III
People: Adaliz Santaliz-Cruz
Libia Lugo
Jose F. Velez

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ID · 3d31f49a-c3dd-4feb-9a88-ddfd46449760