483
Octapharma Plasma IncOctapharma Plasma Inc – FDA 483, Jul 10, 2026
Record Details
During an inspection of Octapharma Plasma Inc in Audubon, NJ, the FDA observed that the firm's plasmapheresis center had inadequate personnel for processing blood and blood components. This deficiency led to a backlog in processing source plasma units, resulting in some units not being frozen within the firm's established Standard Operating Procedure timeframes. These conditions raise concerns about the safety, purity, potency, identity, and effectiveness of the final product.
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ID · 23b791af-1c32-4ed2-9aa5-cf5c68e8c23c
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