CFR section
21 CFR 640.25(b)(4): General requirements
PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS · Subpart C-Platelets
Key facts
| Citation | 21 CFR 640.25(b)(4) |
|---|---|
| Section | General requirements |
| Part | PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS |
| Subpart | Subpart C-Platelets |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Devices, Drugs, Other_Regulations |
| Regulation text (excerpt) | (4) If the results of the quality control testing indicate that the product does not meet the prescribed requirements, immediate corrective action shall be taken and a record maintained of such action. |
At a glance
- 10–99 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.