21 CFR Part 640 · Additional Standards for Human Blood and Blood Products
(a) Storage. Immediately after processing, the Red Blood Cells shall be placed in storage and maintained at a temperature between 1 and 6 °C.
(b) Inspection. The product shall be inspected immediately after separation of the plasma, periodically during storage, and at the time of issue. The product shall not be issued if there is any abnormality in color or physical appearance or if there is any indication of microbial contamination.
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Form FDA 483 observations citing this section, fiscal years 2011–2019 (Biologics).
Federal Register documents that created or amended this section.