483
Global Blood Resources, LLCGlobal Blood Resources, LLC – FDA 483, Jan 17, 2024
Record Details
An FDA inspection of Global Blood Resources, LLC in Windsor, CT, identified a significant issue with their process validation procedures. The firm failed to adequately review, evaluate, and revalidate a sterilization cycle after changes were implemented for their Hemobag blood bags and tubing sets. This indicates a lapse in their design control and change management processes, potentially impacting product sterility assurance.
View Company Profile
ID · b15cdfb3-f3c7-40c0-8568-e24bce5523d8
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.