FDA 483 - CSL Plasma Inc - February 06, 2026

From February 3 to February 6, 2026, the FDA inspected the CSL Plasma Inc. facility in Philadelphia, Pennsylvania. The inspection identified two primary operational failures regarding product safety and regulatory reporting. First, investigators observed improper phlebotomy site preparation. On multiple occasions, staff members failed to maintain sterile conditions, such as touching a donor"s scrubbed skin before needle insertion or failing to apply the antiseptic scrub to the exact venipuncture site. These practices do not provide maximum assurance of a sterile collection process. Second, the facility failed to submit biological product deviation reports within the required 45-day window. In two specific cases involving plasma collected from unsuitable donors, the facility submitted reports late and provided inaccurate discovery dates that did not match internal records.

These observations were recorded under Section 704 of the Federal Food, Drug, and Cosmetic Act. While the report does not represent a final agency determination of compliance, CSL Plasma Inc. is expected to address these findings. The company must implement corrective actions to ensure sterile techniques are followed and that regulatory reports are filed accurately and on time. The firm has the opportunity to formally respond to the FDA with their plan for remediation.