CFR section
21 CFR 640.71(b): Manufacturing responsibility
PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS · Subpart G-Source Plasma
Key facts
| Citation | 21 CFR 640.71(b) |
|---|---|
| Section | Manufacturing responsibility |
| 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) | (b) Such testing shall not be considered divided manufacturing, which requires two biologics licenses for Source Plasma: Provided, That (1) The results of such tests are maintained by the licensed manufacturer of the Source Plasma whereby such results may be reviewed by a responsible physician as required in § 640.65(b)(2) of this chapter and by an authorized representative of the Food and Drug Administration. (2) The Source Plasma manufacturer has obtained a written agreement that the testing… |
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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.