483
CareFusion 213, LLCFDA 483 - CareFusion 213, LLC - September 29, 2023
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Record Details
CareFusion 213, LLC in El Paso, TX, a combination drug/device manufacturer, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in quality control unit procedures, raw material testing, component sampling, facility maintenance, and laboratory controls, including a repeat observation regarding sterility test validation. These issues indicate a moderate level of non-compliance with GMP regulations.
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ID · defb6d8f-9278-4240-a42c-6de4b3d84fec