483
Octapharma Plasma, Inc.Octapharma Plasma, Inc. – FDA 483, Nov 19, 2021
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.
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ID · 069b5621-ec23-447d-b626-b5bba2d5f7e9
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