CSL Plasma – FDA EIR, Feb 16, 2022

An FDA inspection of CSL Plasma's facility in Champaign, IL, occurred from February 15-16, 2022. This comprehensive Level 1 inspection, the first on-site for this new source plasma center, followed Compliance Program 7342.002 for Source Plasma Establishments. A previous desk review in 2020 was satisfactory due to COVID-19 inspection limitations.

The inspection scope covered key systems and records, including Quality Assurance, Donor Eligibility, Product Collection and Processing, and Storage/Quarantine. The investigator reviewed various operational aspects and documentation, such as batch production records, non-reportable events, donor adverse reactions, temperature controls, donor eligibility records, equipment calibration, and materials management. The firm's registration was confirmed to be current and accurate. Notably, the inspection concluded without any observations (Form FDA-483) being issued, indicating no significant violations were identified. Therefore, no specific corrective actions were mandated as a direct result of this inspection. The company was reminded of its general responsibility to comply with all applicable regulatory provisions.