21 CFR Part 640 · Additional Standards for Human Blood and Blood Products
Segments collected in integral tubing shall meet the following standards:
(a) One or more segments shall be provided with each unit of Whole Blood or Red Blood Cells when issued or reissued.
(b) Before they are filled, all segments shall be marked or identified so as to relate them to the donor of that unit of red cells.
(c) All segments accompanying a unit of Red Blood Cells shall be filled at the time the blood is collected or at the time the final product is prepared.
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Form FDA 483 observations citing this section, fiscal years 2016–2016 (Biologics).
Federal Register documents that created or amended this section.