21 CFR 111.353
§ 111.353 What are the requirements under this subpart K for written procedures?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 111.353, § 111.353 What are the requirements under this subpart K for written procedures?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/84188
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Full text
You must establish and follow written procedures for manufacturing operations.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.