FDA 483 - Grifols Therapeutics LLC - April 01, 2014

Grifols Therapeutics Inc. in Clayton, NC, was inspected regarding its plasma fractionation operations. The inspection revealed significant issues including product stability concerns with Albumin, incomplete sterility investigations for Prolastin, inadequate media fill accountability, and poor aseptic practices during filling. Additionally, several facility and equipment maintenance deficiencies were noted, indicating a moderate level of severity.