483
Fresenius Kabi USA LLCFresenius Kabi USA LLC – FDA 483, Dec 11, 2013
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.
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ID · 74b1c598-2a46-48fa-900b-2a48f0906013
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