part_subject: "CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS"
subpart_code: "F"
subpart_subject: "Production and Process Control System: Requirements for Quality Control"
section_number: "111.120"
section_subject: "What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?"
cfr_reference: "21 CFR 111.120"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 100 to 169"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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Quality control operations for components, packaging, and labels before use in the manufacture of a dietary supplement must include:
(a)Reviewing all receiving records for components, packaging, and labels;
(b)Determining whether all components, packaging, and labels conform to specifications established under § 111.70 (b) and (d);
(c)Conducting any required material review and making any required disposition decision;
(d)Approving or rejecting any treatment and in-process adjustments of components, packaging, or labels to make them suitable for use in the manufacture of a dietary supplement; and
(e)Approving, and releasing from quarantine, all components, packaging, and labels before they are used.