FDA 483 - Grifols Therapeutics LLC

An FDA inspection of Grifols Therapeutics LLC in Clayton, NC, revealed significant deficiencies in quality control and manufacturing processes. Key issues include inadequate investigations into adverse event trends leading to product recalls, widespread failures in visual inspection personnel requalification without proper follow-up, and critical shortcomings in environmental monitoring and media growth promotion testing within aseptic processing areas. These findings indicate a lack of robust systems to ensure product quality and patient safety.