FDA EIR - CSL Plasma Inc. - February 24, 2022

An FDA inspection of CSL Plasma Inc.'s licensed Source Plasma collection facility in Port St. Lucie, FL, took place from February 23 to February 24, 2022. This was a comprehensive Level 1 inspection conducted under the regulatory framework of C.P. 7342.002, which governs Source Plasma Establishments. The inspection rigorously evaluated all aspects of the firm's operations, including Quality Assurance, Donor Eligibility, Product Testing, Product Collection and Processing, and Quarantine/Storage/Disposition systems. The inspection involved thorough observations and a review of extensive records, such as donor suitability and screening, medical exams, phlebotomies, adverse events, reactive test results, complaints, and quality management systems. Furthermore, the FDA reviewed recent operational changes, including the implementation of a new Electronic Temperature Monitoring (ETM) system for freezers and the "C-Flex" mobile application for donor health history questionnaires. Significantly, the inspection concluded with no observed violations or issues. The report explicitly states that no significant deficiencies were found, and therefore, no FDA Form 483, Inspectional Observations, was issued to CSL Plasma Inc. This outcome indicates that the facility maintains compliance with federal regulations, and no specific regulatory actions are required from the company based on this inspection.