FDA 483 - Grifols Diagnostic Solutions Inc.

Grifols Diagnostics Solutions, Inc. in Emeryville, CA, was cited for multiple deficiencies related to complaint handling, investigation procedures, and product quality during an inspection of its licensed antigen manufacturing and IVD complaint/distribution operations. The firm failed to properly classify and escalate complaints, notify license holders of potential reportable events, and ensure adequate documentation and evaluation in investigations. These issues indicate a lack of robust quality system controls for managing product deviations and complaints.