FDA 483 - Grifols Biologicals LLC

An FDA inspection of Grifols Biologicals Inc. in City of Industry, CA, a biologic drug manufacturer, revealed significant deficiencies in facility maintenance and quality systems. Observations included a building not maintained in a good state of repair with water damage and structural issues, and a lack of formal agreements and procedures for facility upkeep with a sister corporation. These issues indicate a failure to ensure proper control over the manufacturing environment and related processes.