FDA 483 - Grifols Diagnostic Solutions Inc. - August 26, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
An FDA inspection of Grifols Diagnostic Solutions, INC. in San Diego, CA, revealed significant deficiencies in their quality system as a Medical Device IVD Manufacturer. The firm's procedures for corrective and preventive actions, nonconformance, and product safety risk management were found to be inadequately established. This resulted in failures to properly analyze quality data, identify root causes for nonconforming products, and quantitatively define the probability of harm, as evidenced by multiple complaints regarding missing reagents.
ID · 7c863c07-dfbd-42ab-8d4a-c3bc5a8a2d90