FDA 483 - Grifols Diagnostic Solutions Inc. - December 13, 2024

An FDA inspection of Grifols Diagnostic Solutions Inc. in Emeryville, CA, a licensed antigen component manufacturer for IVDs, revealed significant deficiencies in process validation. The firm failed to appropriately validate the manufacturing process for licensed antigen HCV c100-3, opting for an inadequate verification approach. Additionally, the firm did not conduct required trend analyses of process data across all antigen types to ensure manufacturing processes are in a qualified state.