Octapharma Plasma, Inc.November 19, 2021

FDA 483 - Octapharma Plasma, Inc. - November 19, 2021

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Record Details

An FDA inspection of Octapharma Plasma, Inc.'s plasmapheresis facility in San Pablo, CA, revealed significant deficiencies in quality control and record-keeping. Observations included inadequate protection of Source Plasma containers, failure to investigate seal failures, and a lack of concurrent documentation for critical processing steps. These issues indicate potential risks to product integrity and traceability.

Company: Octapharma Plasma, Inc.
Inspection Date: November 19, 2021
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West V
Person: Roger D. Gawne (issuing_officer)

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ID · 069b5621-ec23-447d-b626-b5bba2d5f7e9