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21 CFR § 111.353 - What are the requirements under this subpart K for written procedures?

---
identifier: "/us/cfr/t21/s111.353"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 111.353 - What are the requirements under this subpart K for written procedures?"
title_number: 21
title_name: "Food and Drugs"
section_number: "111.353"
section_name: "What are the requirements under this subpart K for written procedures?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "111"
part_name: "CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264."
regulatory_source: "72 FR 34942, June 25, 2007, unless otherwise noted."
cfr_part: "111"
---

# 111.353 What are the requirements under this subpart K for written procedures?

You must establish and follow written procedures for manufacturing operations.