Octapharma Plasma IncDecember 11, 2025

FDA 483 - Octapharma Plasma Inc - December 11, 2025

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Octapharma Plasma Inc, a plasmapheresis center in Santa Fe Springs, CA, was cited for deficiencies in its donor screening process. The firm's standard operating procedures for determining donor eligibility, specifically regarding blood pressure measurement, were found to be incomplete. Furthermore, staff were observed failing to adhere to proper blood pressure measurement techniques, potentially compromising the accuracy of donor eligibility assessments.

Company: Octapharma Plasma Inc
Inspection Date: December 11, 2025
Product Type: Biologics
Office: Division of Pharmaceutical Quality Operations IV
Person: Maurine Fadlalla (FDA_PERSONNEL)

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ID · 71fc6cd8-98c9-471f-bb67-fac963c5a712