CFR section
21 CFR 820.120(d): Device labeling
PART 820-QUALITY SYSTEM REGULATION · Subpart K-Labeling and Packaging Control
Key facts
| Citation | 21 CFR 820.120(d) |
|---|---|
| Section | Device labeling |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart K-Labeling and Packaging Control |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, General |
| Regulation text (excerpt) | (d) Labeling operations. Each manufacturer shall control labeling and packaging operations to prevent labeling mixups. The label and labeling used for each production unit, lot, or batch shall be documented in the DHR. |
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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.