CFR section
21 CFR 111.35(b)(1): Under this subpart D, what records must you make and keep?
PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS · Subpart D-Equipment and Utensils
Key facts
| Citation | 21 CFR 111.35(b)(1) |
|---|---|
| Section | Under this subpart D, what records must you make and keep? |
| Part | PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS |
| Subpart | Subpart D-Equipment and Utensils |
| Subchapter | 21 CFR B Food |
| Product types cited | Food/Cosmetics, General |
| Regulation text (excerpt) | (1) Written procedures for fulfilling the requirements of this subpart, including written procedures for: (i) Calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement; (ii) Calibrating, inspecting, and checking automated, mechanical, and electronic equipment; and (iii) Maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components… |
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.