CFR section
21 CFR 111.425: What requirements apply to a packaged and labeled dietary supplement that is rejected for distribution?
PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS · Subpart L-Production and Process Control System: Requirements for Packaging and Labeling Operations
Key facts
| Citation | 21 CFR 111.425 |
|---|---|
| Section | What requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? |
| Part | PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS |
| Subpart | Subpart L-Production and Process Control System: Requirements for Packaging and Labeling Operations |
| Subchapter | 21 CFR B Food |
| Product types cited | Food/Cosmetics |
| Regulation text (excerpt) | You must clearly identify, hold, and control under a quarantine system for appropriate disposition any packaged and labeled dietary supplement that is rejected for distribution. |
At a glance
- 1–9 Inspections citing this section
- 1–9 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.