Fresenius Kabi USA LLCDecember 11, 2013

FDA 483 - Fresenius Kabi USA LLC - December 11, 2013

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Record Details

An FDA inspection of Fresenius Kabi USA LLC in Melrose Park, IL, a sterile injectable drug product manufacturer, revealed significant deficiencies. These included failures in following quality control unit procedures, inadequate equipment design for cleaning, and a lack of established procedures to prevent microbiological contamination. These issues led to product recalls and potential risks to product sterility.

Company: Fresenius Kabi USA LLC
Inspection Date: December 11, 2013
Product Type: Drugs
Office: Chicago District Office
People: Russell K. Riley (Investigator)
John M. Seale (investigator)

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ID · 74b1c598-2a46-48fa-900b-2a48f0906013