FDA 483 - Grifols Biologicals LLC

An FDA inspection of Grifols Biologicals, LLC in City of Industry, CA, a plasma fractionation facility, revealed six observations. Deficiencies included inadequate segregation of products and rejected materials, insufficient temperature control in a staging warehouse, and poor documentation practices for inspections, warehousing procedures, and batch records. These issues indicate a lack of control over product integrity and manufacturing processes.