FDA 483 - Octapharma Plasma Inc - December 11, 2025

An FDA inspection of Octapharma Plasma Inc. in Santa Fe Springs, CA, from December 8-11, 2025, identified a significant deficiency in the firm's standard operating procedures. The SOPs failed to include critical criteria for determining donor eligibility, specifically regarding accurate blood pressure measurement. This omission led to observed instances of noncompliance during donor screenings, potentially compromising the integrity of the donor screening process.