CFR section
21 CFR 640.15(a): Segments for testing
PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS · Subpart B-Red Blood Cells
Key facts
| Citation | 21 CFR 640.15(a) |
|---|---|
| Section | Segments for testing |
| Part | PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS |
| Subpart | Subpart B-Red Blood Cells |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics |
| Regulation text (excerpt) | (a) One or more segments shall be provided with each unit of Whole Blood or Red Blood Cells when issued or reissued. |
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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.