CFR section
21 CFR 820.100(b): Corrective and preventive action
PART 820-QUALITY SYSTEM REGULATION · Subpart J-Corrective and Preventive Action
Key facts
| Citation | 21 CFR 820.100(b) |
|---|---|
| Section | Corrective and preventive action |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart J-Corrective and Preventive Action |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Biologics, Devices, Drugs, Food/Cosmetics, General, Other_Regulations |
| Regulation text (excerpt) | (b) All activities required under this section, and their results, shall be documented. |
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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.