Regulations last checked for updates: May 02, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025
All TitlesTitle 21Chapter IPart 111Subpart E - Subpart E—Requirement to Establish a Production and Process Control System
View all text of Subpart E [§ 111.55 - § 111.95]
§ 111.65 - What are the requirements for quality control operations?

You must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing 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.

authority: 21 U.S.C. 321,342,343,371,374,381,393; 42 U.S.C. 264.
source: 72 FR 34942, June 25, 2007, unless otherwise noted.
cite as: 21 CFR 111.65
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