FDA 483 - Grifols Therapeutics LLC - September 01, 2023

An FDA inspection of Grifols Therapeutics LLC in Clayton, NC, identified several significant deficiencies in their biologic drug manufacturing operations. Key issues included inadequate control over production processes, failures in equipment preventive maintenance, and a lack of established written procedures for critical tasks. Additionally, the facility exhibited poor maintenance of freezers and insufficient control of utility support systems.