CFR section
21 CFR 606.140(a): Laboratory controls
PART 606-CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS · Subpart H-Laboratory Controls
Key facts
| Citation | 21 CFR 606.140(a) |
|---|---|
| Section | Laboratory controls |
| Part | PART 606-CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS |
| Subpart | Subpart H-Laboratory Controls |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Devices, Drugs, Other_Regulations |
| Regulation text (excerpt) | (a) The establishment of scientifically sound and appropriate specifications, standards and test procedures to assure that blood and blood components are safe, pure, potent and effective. |
At a glance
- 10–99 Inspections citing this section
- 1–9 Warning letters citing this section
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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.