483
Fresenius Kabi Austria GMBHFresenius Kabi Austria GMBH – FDA 483, Mar 28, 2023
Record Details
An FDA inspection of Fresenius Kabi Austria GmbH - (FK-Graz) in Graz, Austria, a drug product manufacturer, revealed significant deficiencies across multiple areas. The firm failed to establish or follow adequate process controls, leading to potential contamination risks, issues with aseptic processing, and uncalibrated equipment. Additionally, a utility system was found to be improperly located and maintained, and several manufacturing and validation procedures were deemed deficient.
View Company Profile
ID · c03175d3-f8d3-4a0c-b331-47b2c8e66729
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.