FDA 483 - Grifols Therapeutics LLC

Grifols Therapeutics LLC, a biologic drug manufacturer in Clayton, North Carolina, was cited for significant deficiencies in its aseptic processing procedures. The inspection revealed inadequate documentation for media fill reconciliation and a lack of periodic review for filling line intrusions. Additionally, the firm's bioburden monitoring for pre-sterile bulks was found to be inadequate, with issues in speciation and investigation of microbial findings.