483
Grifols Diagnostic Solutions Inc.Grifols Diagnostic Solutions Inc. – FDA 483, Dec 13, 2024
Record Details
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.
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ID · 51b3d794-1098-4918-9288-0b6b272d627a
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