CFR section
21 CFR 111.83(a): What are the requirements for reserve samples?
PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS · Subpart E-Requirement to Establish a Production and Process Control System
Key facts
| Citation | 21 CFR 111.83(a) |
|---|---|
| Section | What are the requirements for reserve samples? |
| Part | PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS |
| Subpart | Subpart E-Requirement to Establish a Production and Process Control System |
| Subchapter | 21 CFR B Food |
| Product types cited | Devices, Drugs, Food/Cosmetics, General, Veterinary |
| Regulation text (excerpt) | (a) You must collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute. |
At a glance
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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.