483
Grifols Diagnostic Solutions Inc.FDA 483 - Grifols Diagnostic Solutions Inc. - February 27, 2019
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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