21 CFR 111.55
§ 111.55 What are the requirements to implement a production and process control system?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 111.55, § 111.55 What are the requirements to implement a production and process control system?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/84144
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Full text
You must implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.