FDA 483 - Octapharma Plasma Inc. - June 05, 2025

An FDA inspection of Octapharma Plasma Inc., a source plasma collection establishment, took place from May 30, 2025, to June 5, 2025. The inspection resulted in two key observations, highlighting areas needing improvement in the company's operations under the Federal Food, Drug, and Cosmetic Act.

The primary observation noted the firm's failure to adequately determine donor eligibility before plasma collection. Specifically, the company did not assess donors for irregular pulses on the day of donation. Furthermore, donors whose pre-donation blood pressure (outside 90-180 mm Hg systolic or 50-100 mm Hg diastolic) or pulse rate (outside 50-100 beats per minute) fell outside acceptable ranges were neither deferred nor referred to a physician, potentially impacting donor safety.

The second observation concerned procedural documentation. The standard operating procedures lacked written descriptions for essential donor qualifying tests and measurements, including acceptable minimum and maximum values. This specifically applied to the assessment of irregular pulses. To address these findings, Octapharma Plasma Inc. is expected to implement corrective actions, ensuring robust donor screening processes and comprehensive, compliant procedural documentation to meet regulatory standards and safeguard public health.