CFR section
21 CFR 640.67: Laboratory tests
PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS · Subpart G-Source Plasma
Key facts
| Citation | 21 CFR 640.67 |
|---|---|
| Section | Laboratory tests |
| 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 |
| Regulation text (excerpt) | Each unit of Source Plasma shall be tested for evidence of infection due to relevant transfusion-transmitted infections as required under § 610.40 of this chapter. |
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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.