B Positive National Blood Services – FDA 483, Nov 7, 2024

An FDA inspection conducted from November 5-7, 2024, at B Positive National Blood Services, a Source Plasma Collection Facility in Easton, Pennsylvania, resulted in the issuance of a Form FDA 483. This document, addressed to Assistant Director of Quality Assurance William Earley, detailed two significant observations indicating deviations from regulatory expectations under the Federal Food, Drug and Cosmetic Act.

The first observation highlighted the firm's failure to recalibrate a critical measuring device, utilized for quality control checks of plasma collection equipment, by its due date of March 30, 2024. This uncalibrated device was subsequently used, potentially impacting the accurate volume of collected plasma and anticoagulant for numerous Source Plasma units. Accurate calibration is crucial for product quality.

The second observation concerned the lack of a Performance Qualification (PQ) study for the Thermo Scientific Freezers. These freezers have been continuously used since February 20, 2024, for the initial freezing of Source Plasma units, without prior validation to confirm their suitability and compliance with manufacturing requirements.

B Positive National Blood Services is expected to address these observations by implementing prompt corrective actions to ensure all equipment is properly calibrated and qualified according to established procedures, thereby maintaining the integrity and safety of their collected plasma products.