Unknown Company – FDA EIR, May 4, 2022

An FDA GMP inspection of Grifols Therapeutics LLC in Clayton, NC, was conducted from April 28 to May 6, 2022. The inspection, performed as part of the OBPO/Team Biologics FY22 work plan under Compliance Program 7345.848, covered Quality, Production, and Materials systems for licensed biological drug products and intermediates. While previous objectionable conditions from a 2018 inspection were verified as corrected, the current inspection resulted in a Form FDA 483 with two main observations. Firstly, the company failed to establish, write, and follow adequate procedures to prevent microbiological contamination of sterile drug products. This included issues with media fill documentation, periodic quality review of filling line intrusions, and the quality unit's failure to initiate deviations for media fill batches with personnel monitoring discrepancies. Secondly, bioburden monitoring of manufacturing processes leading to pre-sterile bulks was deemed inadequate or inconsistent. Grifols management committed to submitting a written response detailing corrective actions to the FDA. The report also noted the company's involvement in COVID-19 related product development and a market withdrawal of Gamunex-C lots due to donor-related hypersensitivity reactions, which was thoroughly investigated and handled.