Bristol-Myers Squibb Holdings Pharma Ltd. Liability CompanyNovember 19, 2019

FDA 483 - Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company - November 19, 2019

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Record Details

An FDA inspection of Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company in Manati, PR, a sterile drug product manufacturer, revealed multiple significant deficiencies. These included failures in preventing microbiological contamination, inadequate laboratory record-keeping, and a deficient quality control unit. The facility also suffered from pest infestations and lacked proper written procedures for production and process controls, indicating systemic issues impacting drug product quality and purity.

Company: Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company
Inspection Date: November 19, 2019
Product Type: Drugs
Office: Dallas District Office
People: Regina T. Brown (Investigator)
Libia Lugo

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ID · 1a7ca172-8509-4f22-b87f-30ac950c30a1