FDA 483 - Grifols Diagnostic Solutions Inc. - June 28, 2024

Grifols Diagnostic Solutions Inc. in San Diego, CA, an IVD Manufacturer, was cited for multiple significant deficiencies during an FDA inspection. The observations primarily concern inadequate quality system procedures, including issues with process performance qualification, nonconformance handling, environmental control, corrective and preventive actions, batch numbering, document control, manufacturing parameter trending, and documentation practices. These findings indicate a lack of robust controls over critical manufacturing and quality processes.