CSL Plasma Inc. – FDA EIR, May 12, 2022

A routine FDA surveillance inspection of CSL Plasma Inc. in Springfield, OH, took place from May 10-12, 2022. This Level 2 inspection, conducted under Compliance Program 7342.002 for Source Plasma Establishments, focused on the firm's Quality Assurance and Product Collection and Processing systems. The inspection encompassed reviewing standard operating procedures, deviation records, temperature logs, adverse reactions, and observing various processes including donor screening, plasma collection, and processing.

No formal FDA Form 483 (Inspectional Observations) was issued, reflecting a generally compliant history. However, one specific concern was discussed with management: a donor initially identified as literate was later found to be illiterate. Although the donor received appropriate non-reading education materials, a new informed consent form, as mandated by the company's internal procedures for such status changes, was not obtained. CSL Plasma Inc. acknowledged this isolated incident, initiating a new deviation record and committing to implement necessary training and corrective actions. The FDA concluded by reiterating the firm's continuous responsibility to comply with all applicable laws and regulations.