483
Grifols Diagnostic Solutions Inc.Grifols Diagnostic Solutions Inc. – FDA 483, Feb 27, 2019
Record Details
During an inspection, Grifols Diagnostic Solutions Inc. in Emeryville, CA, was cited for three observations. These included issues with software configuration preventing access to original chromatograms, manufacturing of a working seed stock not adhering to the approved BLA, and validation acceptance criteria for column use time limits not reflecting current practices.
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ID · b716cba7-6948-4db1-8eb0-6a099f4cbc96
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