CFR section
21 CFR 640.72(c): Records
PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS · Subpart G-Source Plasma
Key facts
| Citation | 21 CFR 640.72(c) |
|---|---|
| Section | Records |
| Part | PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS |
| Subpart | Subpart G-Source Plasma |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Drugs |
| Regulation text (excerpt) | (c) If a repeat donor is rejected or a donor's plasma is found unsuitable, the donor's record shall contain a full explanation for the rejection. |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.