Grifols Diagnostic Solutions Inc.February 27, 2019

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

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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.

Company: Grifols Diagnostic Solutions Inc.
Inspection Date: February 27, 2019
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West V
Person: Mihaly S. Ligmond (CSO)

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ID · b716cba7-6948-4db1-8eb0-6a099f4cbc96