A Feb 19 to March 12 FDA inspection of Preservation Solutions’ Elkhorn, Wisconsin facility revealed that the firm failed to properly validate its aseptic processes for manufacturing and processing sterile organ transplant preservation solutions.
The facility’s test data didn’t support specified requirements for several lots of product, and the firm didn’t handle this as a protocol deviation or failure of the initial or subsequent testing.
“Your firm lacks an approved process validation for the bag leak test of the sterile organ transplant preservation solution at the time of final packaging for distribution,” the Form 483 report states, noting that complaints were received that led to a recall of the solution.
