FDA 483 - Grifols Biologicals LLC

Grifols Biologicals, LLC in Los Angeles, CA, was cited for significant manufacturing and quality control deficiencies during an FDA inspection. The firm experienced multiple recalls of its IGIV-C product due to serious allergic reactions, failed to conduct thorough investigations into these issues, and exhibited inadequate procedures for adverse event evaluation, complaint handling, and microbiological contamination prevention. The observations highlight a systemic breakdown in quality systems, including training and laboratory controls, posing a risk to product quality and patient safety.