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21 CFR 640.11

§ 640.11 General requirements.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 640.11, § 640.11 General requirements, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88469
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(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.