Grifols Therapeutics LLC – FDA EIR, May 6, 2022

An FDA Good Manufacturing Practice (GMP) inspection was conducted at Grifols Therapeutics LLC in Clayton, NC, from April 28, 2022, to May 06, 2022. This was a preannounced Level 2 inspection focused on the manufacture of licensed biological drug products, in line with Compliance Program 7345.848. The inspection covered Quality, Production, and Materials systems. Notably, previous objectionable conditions identified in a 2018 inspection were verified as corrected. During the current inspection, the firm received a Form FDA 483 citing two main issues. First, procedures to prevent microbiological contamination of sterile drug products were found to be inadequate. This included deficiencies in media fill documentation, periodic quality review of filling line intrusions, and the quality unit's failure to initiate a deviation for a media fill batch where personnel monitoring records indicated an operator exited the room before sampling. Second, bioburden monitoring for manufacturing processes producing pre-sterile bulk products was deemed inadequate or inconsistent. Grifols management has committed to submitting a written response detailing corrective actions to the U.S. FDA.