Blood for Reagent Red Blood Cells from donors of peripheral blood shall be collected as prescribed under § 640.4 of this chapter , except that paragraphs (c), (d), (g), and (h) of § 640.4 shall not apply.
21 CFR Part 660 · Additional Standards for Diagnostic Substances for Laboratory Tests
§ 660.32 Collection of source material
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What FDA inspectors cite under § 660.32
Form FDA 483 observations citing this section, fiscal years 2009–2013 (Biologics).
- Same as for whole blood 3