483
CSL Plasma Inc.CSL Plasma Inc. – FDA 483, Aug 5, 2019
Record Details
CSL Plasma, Inc. in Philadelphia, PA, was cited for significant deficiencies in donor screening and eligibility determination processes, including the use of incorrect gender-specific health history questionnaires. The inspection also revealed a failure to thoroughly investigate a trend of plasma overharvests and a failure to submit required biological product deviation reports. These issues indicate serious concerns regarding donor safety and product quality control.
View Company Profile
ID · 809140b6-e371-46e3-aff1-88713746516b
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.