CFR section
21 CFR 640.81(c): Processing
PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS · Subpart H-Albumin (Human)
Key facts
| Citation | 21 CFR 640.81(c) |
|---|---|
| Section | Processing |
| Part | PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS |
| Subpart | Subpart H-Albumin (Human) |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Devices, Drugs, Food/Cosmetics |
| Regulation text (excerpt) | (c) Microbial contamination. All processing steps shall be conducted in a manner to minimize the risk of contamination from microorganisms, pyrogens, or other impurities. Preservatives to inhibit growth of microorganisms shall not be used during processing. |
At a glance
- 1–9 Inspections citing this section
- None Warning letters citing this section
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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.